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| ID | Type | Description | Link |
|---|---|---|---|
| 11903 | Registry Identifier | DAIDS ES |
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The purpose of this study was to assess the safety and pharmacokinetics (PK) of three monoclonal antibodies, VRC01, VRC01LS, and VRC07-523LS, in HIV-exposed infants who are at increased risk of mother-to-child HIV transmission.
VRC01, VRC01LS, and VRC07-523LS are anti-HIV neutralizing monoclonal antibodies that may help prevent mother-to-child transmission of HIV. This study enrolled HIV-infected mothers who were at increased risk of passing HIV on to their children. The purpose of this study was to assess the safety and PK of VRC01, VRC01LS, and VRC07-523LS in HIV-exposed infants.
This study enrolled mother-infant pairs into five dose groups. Infants enrolled in Dose Group 1 and Dose Group 2 received a single VRC01 injection less than 72 hours after birth. Infants in Dose Group 3 received a VRC01 injection less than 5 days after birth, followed by VRC01 injections monthly for at least 6 months and no more than 18 months, while breastfeeding.
Dose Groups 4 and 5 each enrolled infants into two cohorts: Cohort 1 (non-breastfeeding) or Cohort 2 (breastfeeding). Infants in Dose Group 4, Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Infants in Dose Group 4, Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth, and a second VRC01LS injection at Week 12 if they were still breastfeeding. Infants in Dose Group 5, Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Infants in Dose Group 5, Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth, and a second VRC07-523LS injection at Week 12 if they were still breastfeeding.
The mothers did not receive any VRC01, VRC01LS, or VRC07-523LS injections. At study entry, all mothers underwent a medical history review and a blood collection, and then the study ended for the mothers.
Infants in Dose Groups 1 and 2 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks 8, 16, 24, and 48. Infants in Dose Group 3 attended study visits at days 0, 1, 14, 28 and at weeks 8, 12, 16, 20, 24, and every 4 weeks until cessation of breastfeeding or week 72, then at weeks 84 and 96. Infants in Dose Group 4 attended study visits at days 0, 1, 14, 28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for Cohort 2 participants. Infants in Dose Group 5 attended study visits at days 0, 1, 3, 7, 14, 28 and at weeks 8, 12, 24, 36, 48, 60, 72, 84 and 96, with additional visits at weeks 14 and 16 for Cohort 2 participants. Visits included a medical history review, physical examination, blood collection, and oral fluid collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 | Experimental | Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. |
|
| Dose Group 2 | Experimental | Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. |
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| Dose Group 3 | Experimental | Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. |
|
| Dose Group 4, Cohort 1 | Experimental | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. |
|
| Dose Group 4, Cohort 2 | Experimental | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC01 | Biological | Administered by subcutaneous injection in the thigh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died | The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included. | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
| Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included. | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
| Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included. | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
| Percentage of Participants Diagnosed With HIV Infection | The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4). |
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Maternal Inclusion Criteria:
Maternal Exclusion Criteria:
Infant Inclusion Criteria:
Born to an HIV-1-infected woman who met all maternal inclusion/exclusion criteria listed above
Gestational age, by best obstetrical, ultrasound, or infant exam, greater than or equal to 36 weeks
Birth weight greater than or equal to 2.0 kg
Allowable infant age at the time of enrollment was dependent on the Dose Group and Cohort:
At increased risk of HIV acquisition defined as documentation of one or more of the following risk factors:
Dose Groups 1, 2, 4 and 5 (Cohort 1), only:
Mother received no antiretroviral therapy (ART) during pregnancy or mother began or reinitiated ART (after an interruption of greater than 14 days), during the third trimester of pregnancy; or
Mother with any detectable viral replication (HIV RNA above the limit of detection) at last measurement prior to delivery determined within 30 days of delivery; or
Prolonged rupture of membranes (greater than 12 hours); or
Mother with documented 2-class resistant HIV infection, which may have included historical documentation of lack of response
Dose Groups 3, 4 and 5 (Cohort 2), only (African sites):
Infant Exclusion Criteria:
Receipt of any other active or passive HIV immunotherapy or investigational product other than the study vaccine (Note: Infant prophylaxis with any licensed ARV drugs clinically prescribed to prevent mother-to-child HIV transmission were not considered investigational.)
Receipt of or anticipated need for blood products, immunoglobulin, or immunosuppressive therapy. This included infants who required hepatitis B immunoglobulin (HBIG) but did not require exclusion of infants who received hepatitis B vaccine in the newborn period.
Documented or suspected serious medical illness, serious congenital anomaly, or immediate life-threatening condition in the infant that may have interfered with the ability to complete study requirements, as judged by the examining clinician
Any requirement for supplemental oxygen beyond 24 hours of life or requiring supplemental oxygen at the time of the VRC01, VRC01LS, or VRC07-523LS dose
Baseline laboratory results:
Dose Groups 1, 2, 4 and 5 (Cohort 1), only: Infant was breastfeeding at time of enrollment or mother had indicated an intention to initiate breastfeeding. Note: if a child was breastfed prior to known maternal diagnosis (in the case of a woman diagnosed in the intrapartum period), the child was still eligible as long as breastfeeding was stopped by the time the child was enrolled and there was no plan to resume breast milk feeding.
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| Name | Affiliation | Role |
|---|---|---|
| Coleen Cunningham, MD | Duke University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA NICHD CRS | Los Angeles | California | 90095-1752 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31681963 | Result | Cunningham CK, McFarland EJ, Morrison RL, Capparelli EV, Safrit JT, Mofenson LM, Mathieson B, Valentine ME, Perlowski C, Smith B, Hazra R, Purdue L, Muresan P, Harding PA, Mbengeranwa T, Robinson LG, Wiznia A, Theron G, Lin B, Bailer RT, Mascola JR, Graham BS; IMPAACT P1112 team. Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants. J Infect Dis. 2020 Jul 23;222(4):628-636. doi: 10.1093/infdis/jiz532. | |
| 34009371 |
| Label | URL |
|---|---|
| Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017) | View source |
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Dose groups enrolled sequentially. There was no randomization.
83 mother-infant pairs were enrolled in the study. Since the mothers did not receive any treatment on study and were taken off study immediately after enrollment, the number of participants shown in all tables is the number of infants (83). Participants were enrolled from June 2015 to February 2020, at 14 medical clinics in the United States, Puerto Rico, South Africa and Zimbabwe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Group 1 | Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh |
| FG001 | Dose Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2020 | Jun 7, 2021 |
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| Dose Group 5, Cohort 1 | Experimental | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. |
|
| Dose Group 5, Cohort 2 | Experimental | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. |
|
| VRC01LS | Biological | Administered by subcutaneous injection in the thigh |
|
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| VRC07-523LS | Biological | Administered by subcutaneous injection in the thigh |
|
|
| From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
| Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized. | Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84. |
| Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized. | Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84. |
| Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4. | Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84. |
| Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days). | Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84. |
| Percentage of Participants Who Died After Last Immunization for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
| Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4). |
| Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
| Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4). |
| Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
| Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4 | The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4). |
| Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
| Number of Participants Who Developed Anti-VRC Antibodies | The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies. | At weeks 24 and 48. |
| Univ. of Colorado Denver NICHD CRS |
| Aurora |
| Colorado |
| 80045 |
| United States |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | United States |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | United States |
| Pediatric Perinatal HIV Clinical Trials Unit CRS | Miami | Florida | 33136 | United States |
| Emory University School of Medicine NICHD CRS | Atlanta | Georgia | 30322 | United States |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | United States |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | United States |
| Jacobi Med. Ctr. Bronx NICHD CRS | The Bronx | New York | 10461 | United States |
| Texas Children's Hospital CRS | Houston | Texas | 77030-2399 | United States |
| San Juan City Hosp. PR NICHD CRS | San Juan | PR | 00936 | Puerto Rico |
| University of Puerto Rico Pediatric HIV/AIDS Research Program CRS | San Juan | 00935 | Puerto Rico |
| Famcru Crs | Tygerberg | Western Cape | 7505 | South Africa |
| Harare Family Care CRS | Harare | Zimbabwe |
| Result |
| McFarland EJ, Cunningham CK, Muresan P, Capparelli EV, Perlowski C, Morgan P, Smith B, Hazra R, Purdue L, Harding PA, Theron G, Mujuru H, Agwu A, Purswani M, Rathore MH, Flach B, Taylor A, Lin BC, McDermott AB, Mascola JR, Graham BS; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1112 Team. Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1-Exposed Newborn Infants. J Infect Dis. 2021 Dec 1;224(11):1916-1924. doi: 10.1093/infdis/jiab229. |
| Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010 | View source |
Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth.
VRC01: Administered by subcutaneous injection in the thigh
| FG002 | Dose Group 3 | Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh |
| FG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| FG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
| FG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| FG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were collected only for infants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Group 1 | Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh |
| BG001 | Dose Group 2 | Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. VRC01: Administered by subcutaneous injection in the thigh |
| BG002 | Dose Group 3 | Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. VRC01: Administered by subcutaneous injection in the thigh |
| BG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| BG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
| BG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| BG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Birth Weight | Median | Full Range | grams |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Died | The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Deaths from day 0 to 4 weeks after the participants' last immunization were included. | All infant study participants. | Posted | Number | 90% Confidence Interval | percentage of participants | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
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| Primary | Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included. | All infant study participants. | Posted | Number | 90% Confidence Interval | percentage of participants | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
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| Primary | Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed and determined if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Adverse events from day 0 to 4 weeks after the participants' last immunization were included. | All infant study participants. | Posted | Number | 90% Confidence Interval | percentage of participants | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
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| Primary | Percentage of Participants Diagnosed With HIV Infection | The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. HIV diagnoses from day 0 to 4 weeks after the participants' last immunization were included. | All infant study participants. | Posted | Number | 90% Confidence Interval | percentage of participants | From day 0 to 4 weeks after last immunization (at week 4 for Dose Groups 1, 2, 4-Cohort 1, 5-Cohort 1; at week 16-48 for Dose Group 3; at week 16 for Dose Group 4-Cohort 2, 5-Cohort 2.) |
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| Primary | Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-28 days (area-under-the-curve from 0 to 28 days) for Dose Groups 1, 2 and 3 and AUC0-84 days for Dose Group 4, were determined using the linear trapezoidal rule. Median and range were summarized. | Infants who received the correct dose and were evaluated for PK at the designated timepoints. | Posted | Median | Full Range | mcg*d/mL | Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84. |
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| Primary | Pharmacokinetics (PK) Parameter: Area Under the Curve (AUC) for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). AUC0-84 days (area-under-the-curve from 0 to 84 days) were determined using the linear trapezoidal rule. Median and range were summarized. | Participants who received the correct dose and were evaluated for PK at the designated timepoints. | Posted | Median | Full Range | mcg*d/mL | Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84. |
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| Primary | Pharmacokinetics (PK) Parameter: Concentration for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C28 days (concentration at 28 days) for Dose Groups 1, 2 and 3 and C84 days for Dose Group 4. | Infants who received the correct dose and were evaluated for PK at the designated timepoints. | Posted | Median | Full Range | mcg/mL | Dose Groups (DG) 1, 2: at days 0, 1, 3, 7, 14, 28; DG 3: at days 0, 1, 14, 28, weeks 16, 20, 24; DG 4-Cohort 1: at days 0, 1, 14, 28; Cohort 2: at days 0, 1, 14, 28, 84. |
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| Primary | Pharmacokinetics (PK) Parameter: Concentration for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. PK parameters were determined from plasma concentration-time profiles using noncompartmental methods (SAS 9.4, Cary, NC). Median and range were summarized for C84 days (concentration at 84 days). | Participants who received the correct dose and were evaluated for PK at the designated timepoints. | Posted | Median | Full Range | mcg/mL | Dose Group 5 - Cohort 1: at days 0, 1, 3, 7, 14, 28; Cohort 2: at days 0, 1, 3, 7, 14, 28, 84. |
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| Secondary | Percentage of Participants Who Died After Last Immunization for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Group 3 and 4). |
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| Secondary | Percentage of Participants Who Died After Last Immunization for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
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| Secondary | Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Groups 1, 2, 3 and 4 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4). |
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| Secondary | Percentage of Participants With an Occurrence of at Least One Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Group 5 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
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| Secondary | Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization For Dose Groups 1, 2, 3, and 4 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4). |
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| Secondary | Percentage of Participants With at Least One VRC01-, VRC01LS-, or VRC07-523LS-related Grade 3 or Higher Adverse Event (AE) After Last Immunization for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. AE severity grading was based on the Division of AIDS (DAIDS) AE Grading table, Corrected Version 2.1. The study sites assessed if AEs were related to study treatment. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
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| Secondary | Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Groups 1, 2, 3, and 4 | The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. Data for Dose Groups 1, 2, 3 and 4 are presented here. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3 and 4). |
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| Secondary | Percentage of Participants Diagnosed With HIV Infection After Last Immunization for Dose Group 5 | The Overall Number of Participants Analyzed represents infants. Diagnosis testing was performed using a HIV-1 NAT (nucleic acid testing) by a method that detects DNA. Two-sided 90% exact Clopper-Pearson confidence intervals (CI) were calculated. | All infants enrolled in these Dose Groups. | Posted | Number | 90% Confidence Interval | percentage of participants | From four weeks after the participants' last immunization to the end of the study follow-up (at week 96 for Dose Group 5). |
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| Secondary | Number of Participants Who Developed Anti-VRC Antibodies | The Overall Number of Participants Analyzed represents infants with samples collected and tested. The number of infants who developed anti antibodies to the study products are summarized. For Dose Groups 1, 2, and 3, these are anti-VRC01 antibodies. For Dose Group 4, these are anti-VCR07 antibodies and for Dose Group 5, these are anti-VRC07-523LS antibodies. | Infant study participants with samples collected and tested. | Posted | Count of Participants | Participants | At weeks 24 and 48. |
|
From study entry to study completion at week 48 for Dose Groups 1 and 2 and at week 96 for Dose Groups 3, 4, and 5.
Reactogenicity AEs, all grade 2 AEs assessed as possibly, probably or definitely related to the study product, and all AEs grade 3 or higher, were only collected for infants, throughout the study. Grade 1 AEs (other than reactogenicity) or grade 2 AEs not related to study product were collected until 30 days after the final immunization. AE severity grading was based on DAIDS AE Grading Table, Corrected Version 2.1. Serious adverse events (SAE) were reported according to DAIDS EAE Manual V2.0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Group 1 | Infants in Dose Group 1 received a single VRC01 20 mg/kg injection less than 72 hours after birth. | 0 | 13 | 4 | 13 | 13 | 13 |
| EG001 | Dose Group 2 | Infants in Dose Group 2 received a single VRC01 40 mg/kg injection less than 72 hours after birth. | 0 | 14 | 1 | 14 | 13 | 14 |
| EG002 | Dose Group 3 | Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding. | 0 | 13 | 0 | 13 | 13 | 13 |
| EG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. | 0 | 10 | 2 | 10 | 9 | 10 |
| EG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. | 0 | 11 | 0 | 11 | 11 | 11 |
| EG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. | 0 | 11 | 6 | 11 | 11 | 11 |
| EG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. | 0 | 11 | 1 | 11 | 10 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| ABO haemolytic disease of newborn | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infantile spitting up | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia neonatal | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neonatal tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Congenital pigmentation disorder | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Congenital umbilical hernia | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Naevus flammeus | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sickle cell trait | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Strabismus congenital | Congenital, familial and genetic disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Coating in mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation neonatal | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea neonatal | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infantile colic | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infantile spitting up | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infantile vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug withdrawal syndrome neonatal | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fever neonatal | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Withdrawal syndrome | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ocular icterus | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Neonatal candida infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Ophthalmia neonatorum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic rash | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Exposure to communicable disease | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Eyelid abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bicarbonate | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Capillary nail refill test abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Carbon dioxide decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Faecal volume decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Liver palpable | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Poor feeding infant | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acquired plagiocephaly | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Growth failure | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Agitation neonatal | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fontanelle bulging | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infant irritability | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tremor neonatal | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Caput succedaneum | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| Neonatal disorder | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| Poor weight gain neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| Umbilical granuloma | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decrease neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Selective eating disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Genital macule | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Genital swelling | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Penile rash | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Perineal erythema | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Scrotal dermatitis | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal erythema | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal rash | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Grunting | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Irregular breathing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal plaque | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Use of accessory respiratory muscles | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema toxicum neonatorum | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Milia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash neonatal | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Transient neonatal pustular melanosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Umbilical haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Allen, Director, IMPAACT Operations Center | Family Health International (FHI 360) | (919) 405-1429 | mallen@fhi360.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2020 | Jun 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| South Africa |
|
| Zimbabwe |
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| OG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh |
|
|
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| OG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh |
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| OG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh |
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Infants in Dose Group 3 received a VRC01 40 mg/kg injection less than 5 days after birth. They then received a VRC01 20 mg/kg injection monthly for at least 6 months and no more than 18 months while breastfeeding.
VRC01: Administered by subcutaneous injection in the thigh
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
|
|
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Dose Group 4, Cohort 1 | Infants in Cohort 1 received a single VRC01LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG004 | Dose Group 4, Cohort 2 | Infants in Cohort 2 received an initial VRC01LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC01LS was administered at Week 12 if an infant was still breastfeeding. VRC01LS: Administered by subcutaneous injection in the thigh |
| OG005 | Dose Group 5, Cohort 1 | Infants in Cohort 1 received a single VRC07-523LS injection less than 72 hours after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. VRC07-523LS: Administered by subcutaneous injection in the thigh |
| OG006 | Dose Group 5, Cohort 2 | Infants in Cohort 2 received an initial VRC07-523LS injection no longer than 5 days after birth. Dose was based on weight: 80 mg for infants weighing less than 4.5 kg and 100 mg for infants weighing 4.5 kg or greater. A second dose of 100 mg VRC07-523LS was administered at Week 12 if an infant was still breastfeeding. VRC07-523LS: Administered by subcutaneous injection in the thigh |
|
|