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| Name | Class |
|---|---|
| The PATH Malaria Vaccine Initiative (MVI) | OTHER |
| Crucell Holland BV | INDUSTRY |
This study will evaluate whether administration of two investigational malaria vaccines (257049 and Ad35.CS.01 vaccines) combined in one immunization schedule increases protection against malaria infection as compared to protection induced by the 257049 vaccine alone. The study will also evaluate the safety and the immune response to the new combination of the two experimental malaria vaccines.
Approximately 168 healthy, malaria-naïve volunteers aged 18 - 50 years, divided into 2 groups (84 in each group), will receive either one dose of Ad35.CS.01 followed by two doses of 257049 at monthly intervals or 3 doses of 257049 vaccine at monthly intervals. Of these, a maximum of 138 vaccinated volunteers will be challenged with P. falciparum infected mosquitoes. The challenge will occur 2 weeks following the third immunization. A group of up to 18 infectivity controls will begin participation in the study at the challenge stage. These controls receive no vaccine and are enrolled for malaria-challenge only in order to provide comparison group for vaccinated individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ad35.CS.01 Group | Experimental | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
|
| GSK257049 Group | Experimental | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
|
| Control Group | Experimental | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01) | Biological | One dose will be administered intramuscularly at Study Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge | P. falciparum parasitemia was defined as a positive blood slide. | 28 days following sporozoite challenge (Day 105) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors [uncontrollable shivering more than (>) 15 seconds]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge | The onset of P. falciparum parasitemia was defined by a positive blood slide. | From day of challenge (Day 0) up to 159 days post-challenge |
| Anti-circumsporozoite Protein (Anti-CS) Antibody Titers |
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Inclusion Criteria:
Subjects who the investigator believes can and will comply with the requirements of the protocol.
A male or non-pregnant female 18 to 50 years of age at the time of first vaccination.
Written informed consent obtained from the subject before screening procedures.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Available to participate for the duration of the study.
Female subjects of non-childbearing potential.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Pass a comprehension assessment test.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26148007 | Background | Ockenhouse CF, Regules J, Tosh D, Cowden J, Kathcart A, Cummings J, Paolino K, Moon J, Komisar J, Kamau E, Oliver T, Chhoeu A, Murphy J, Lyke K, Laurens M, Birkett A, Lee C, Weltzin R, Wille-Reece U, Sedegah M, Hendriks J, Versteege I, Pau MG, Sadoff J, Vanloubbeeck Y, Lievens M, Heerwegh D, Moris P, Guerra Mendoza Y, Jongert E, Cohen J, Voss G, Ballou WR, Vekemans J. Ad35.CS.01-RTS,S/AS01 Heterologous Prime Boost Vaccine Efficacy against Sporozoite Challenge in Healthy Malaria-Naive Adults. PLoS One. 2015 Jul 6;10(7):e0131571. doi: 10.1371/journal.pone.0131571. eCollection 2015. | |
| 39377226 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114460 | Clinical Study Report | View IPD |
Patient-level data for this study is available via the Clinical Study Data Request site (click on the link provided below)
Patient-level data for this study is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ad35.CS.01 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSK Biologicals' malaria vaccine 257049 (2 doses) | Biological | Two doses will be administered intramuscularly at monthly intervals |
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| GSK Biologicals' malaria vaccine 257049 (3 doses) | Biological | Three doses will be administered intramuscularly at monthly intervals |
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| Sporozoite challenge | Other | Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination. |
|
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | Within the 30-day (Day 0 - Day 29) follow-up period post-challenge |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Throughout the study period (Day 0 - Day 236) |
Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. |
| 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Anti-hepatitis B (Anti-HBs) Antibody Titers | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Frequency of HBs-specific CD4+ T-cells | HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Frequency of CS-specific T-cells Producing IFN-γ | The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
| Frequency of CS-specific T-cells Producing IFN-γ | The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). | 14 days post-dose 1 (Day 14) |
| Derived |
| Spreng RL, Seaton KE, Lin L, Hilliard S, Horn GQ, Abraha M, Deal AW, Li K, Carnacchi AJ, Feeney E, Shabbir S, Zhang L, Bekker V, Mudrak SV, Dutta S, Mercer LD, Gregory S, King CR, Wille-Reece U, Jongert E, Kisalu NK, Tomaras GD, Dennison SM. Identification of RTS,S/AS01 vaccine-induced humoral biomarkers predictive of protection against controlled human malaria infection. JCI Insight. 2024 Oct 8;9(19):e178801. doi: 10.1172/jci.insight.178801. |
| 36875126 | Derived | Li K, Dodds M, Spreng RL, Abraha M, Huntwork RHC, Dahora LC, Nyanhete T, Dutta S, Wille-Reece U, Jongert E, Ewer KJ, Hill AVS, Jin C, Hill J, Pollard AJ, Munir Alam S, Tomaras GD, Dennison SM. A tool for evaluating heterogeneity in avidity of polyclonal antibodies. Front Immunol. 2023 Feb 16;14:1049673. doi: 10.3389/fimmu.2023.1049673. eCollection 2023. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114460 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114460 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114460 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114460 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114460 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| GSK257049 Group |
Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
| FG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ad35.CS.01 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
| BG001 | GSK257049 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
| BG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
| BG003 | 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, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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 | Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge | P. falciparum parasitemia was defined as a positive blood slide. | The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available. | Posted | Count of Participants | Participants | 28 days following sporozoite challenge (Day 105) |
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| Primary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. | The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in. | Posted | Count of Participants | Participants | Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination |
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| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors [uncontrollable shivering more than (>) 15 seconds]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in. | Posted | Count of Participants | Participants | Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination |
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| Primary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination |
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| Primary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group. | Posted | Count of Participants | Participants | Within the 30-day (Day 0 - Day 29) follow-up period post-challenge |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group. | Posted | Count of Participants | Participants | Throughout the study period (Day 0 - Day 236) |
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| Secondary | Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge | The onset of P. falciparum parasitemia was defined by a positive blood slide. | The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available. | Posted | Mean | Standard Deviation | Days | From day of challenge (Day 0) up to 159 days post-challenge |
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| Secondary | Anti-circumsporozoite Protein (Anti-CS) Antibody Titers | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Anti-hepatitis B (Anti-HBs) Antibody Titers | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points | Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells | CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Mean | Standard Deviation | T-cells/million PBMCs | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells | CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Mean | Standard Deviation | T-cells/million PBMCs | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Frequency of HBs-specific CD4+ T-cells | HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Mean | Standard Deviation | T-cells/million PBMCs | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Frequency of CS-specific T-cells Producing IFN-γ | The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77. | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Mean | Standard Deviation | spots/million PBMCs | 14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236) |
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| Secondary | Frequency of CS-specific T-cells Producing IFN-γ | The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). | The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available. | Posted | Mean | Standard Deviation | spots/million PBMCs | 14 days post-dose 1 (Day 14) |
|
Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 31-day post-vaccination (Days 0-30). SAEs: during the entire study period (Day 0 - Day 236).
Not provided
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 | Ad35.CS.01 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. | 0 | 28 | 0 | 28 | 27 | 28 |
| EG001 | GSK257049 Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. | 0 | 27 | 0 | 27 | 27 | 27 |
| EG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. | 0 | 12 | 0 | 12 | 12 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea (post-vaccination) | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Fatigue (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Malaise (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Pain (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Nasopharyngitis (post-vaccination) | Infections and infestations | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Upper respiratory tract infection (post-vaccination) | Infections and infestations | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Arthralgia (post-vaccination) | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Back pain (post-vaccination) | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Headache (post-vaccination) | Nervous system disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Dysmenorrhoea (post-vaccination) | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Nasal congestion (post-vaccination) | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Hyperhidrosis (post-vaccination) | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Pruritus (post-vaccination) | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Malaria (post-challenge) | Infections and infestations | MedDRA 15.1 | Systematic Assessment | For the post-challenge period, 25 subjects from AD35.CS.01 Group and 21 subjects from GSK257049 Group participated in the challenge procedures and had results available. |
|
| Headache (post-challenge) | Nervous system disorders | MedDRA 15.1 | Systematic Assessment | For the post-challenge period, 25 subjects from AD35.CS.01 Group and 21 subjects from GSK257049 Group participated in the challenge procedures and had results available. |
|
| Oropharyngeal pain(post-challenge) | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment | For the post-challenge period, 25 subjects from AD35.CS.01 Group and 21 subjects from GSK257049 Group participated in the challenge procedures and had results available. |
|
| Nausea (post-challenge) | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment | For the post-challenge period, 25 subjects from AD35.CS.01 Group and 21 subjects from GSK257049 Group participated in the challenge procedures and had results available. |
|
| Upper respiratory tract infection (post-challenge) | Infections and infestations | MedDRA 15.1 | Systematic Assessment | For the post-challenge period, 25 subjects from AD35.CS.01 Group and 21 subjects from GSK257049 Group participated in the challenge procedures and had results available. |
|
| Pruritus (post-challenge) | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment | For the post-challenge period, 25 subjects from AD35.CS.01 Group and 21 subjects from GSK257049 Group participated in the challenge procedures and had results available. |
|
| Pain- solicited local (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Redness (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Swelling (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Chills (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Fatigue (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Gastrointestinal symptoms (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Headache- solicited general (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
| Temperature (post-vaccination) | General disorders | MedDRA 15.1 | Systematic Assessment | Subjects from Control Group did not receive any vaccination. |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| Male |
|
| American Indian or Alaskan native |
|
| Asian - Central/South Asian heritage |
|
| White - Caucasian/European heritage |
|
| Mixed Origin |
|
| Other |
| Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model. | 2-sided Fisher Exact test | 0.0066 | Vaccine Efficacy: Maentel-Haenzel Method | 44.0 | 2-Sided | 95 | 20.7 | 60.4 | Other |
| Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model. | 2-sided Fisher Exact test | 0.0021 | Vaccine Efficacy: Maentel-Haenzel Method | 52.4 | 2-Sided | 95 | 25.4 | 69.6 | Other |
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects. |
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
| OG002 | Control Group | Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|