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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000017-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Statens Serum Institut | OTHER |
| Novavax | INDUSTRY |
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This is a first-in-human phase I, open-label, single-site, dose escalation study to determine the safety, tolerability and Plasmodium falciparum transmission reducing activity of the R0.6C vaccine in two different adjuvant combinations.
Thirty-two healthy adult volunteers will be recruited and divided over the study arms that will receive four vaccinations on days 0, 28, 56 and 168 with either 30μg or 100μg of R0.6C adjuvanted with Alhydrogel alone, or combined with Matrix-M1.
Three volunteers (Group 1A, n=3) will receive four vaccinations with the lower dose of 30μg R0.6C with Alhydrogel, and, in parallel, three volunteers (Group 1B, n=3) will receive four vaccinations with the lower dose of 30μg R0.6C with Alhydrogel and Matrix-M1. Volunteers will be closely monitored for adverse events for a period of minimally 14 days after the first vaccination. If safe, an additional 5 volunteers per adjuvant arm (groups 2A and 2B) will then receive four vaccinations with the lower dose (30μg R0.6C). If considered safe following a minimum of 14 days of follow-up after the first R0.6C administration of groups 2A and 2B, three volunteers per adjuvant arm (groups 3A and 3B) will start the vaccination regimen with the higher dose of 100μg R0.6C. Finally, a minimum of 14 days after administration of the first vaccination in groups 3A and 3B, if considered safe, an additional 5 volunteers per adjuvant arm (groups 4A and 4B) will initiate the vaccination regimen with the higher dose of 100μg R0.6C. There will be no placebo group. All volunteers will be followed up for adverse events until 84 days after the last immunisation. Total trial duration is approximately 8 months for each subject. Blood will be collected to assess functional Plasmodium falciparum transmission reducing activity (TRA) and transmission blocking activity (TBA) by standard membrane feeding assay (SMFA), as well as immunogenicity, at pre-specified time points after R0.6C vaccinations compared to pre-vaccination values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A 30μg R0.6C Alhydrogel | Experimental | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
|
| 1B 30μg R0.6C Alhydrogel + Matrix M1 | Experimental | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
|
| 2A 30μg R0.6C Alhydrogel | Experimental | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
|
| 2B 30μg R0.6C Alhydrogel + Matrix M1 | Experimental | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
|
| 3A 100μg R0.6C Alhydrogel | Experimental | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R0.6C transmission blocking vaccine | Biological | Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events and Grade 3 Adverse Events | The number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization. | From first immunization up to 84 days after the last immunization |
| Transmission Reducing Activity | The functional transmission reducing activity in the standard membrane feeding assay of volunteer sera collected two weeks after the fourth R0.6C immunization (I4+14), compared to baseline (I1-1) within each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I4+14 sera by total number of oocysts in mosquitoes fed with I1-1 sera. | 14 days after the fourth immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Grade 1 and 2 Adverse Events | The number of solicited and unsolicited grade 1 and 2 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization. | From first immunization up to 84 days after the last immunization |
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Inclusion Criteria:
Exclusion Criteria:
Acute or chronic disease at time of R0.6C administration, clinically significant pulmonary, cardiovascular, hepatic, renal, neurological or immunological functional abnormality, as determined by medical history, physical examination or laboratory screening tests:
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
Chronic use of i) immunosuppressive drugs, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.
History of drug or alcohol abuse interfering with normal social function in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening or at inclusion.
Screening tests positive for Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
Use of any other investigational or non-registered product (drug or vaccine) during the study period.
Known hypersensitivity to macrolides.
Participation in any other clinical study involving an investigational product in the 30 days prior to the start of the study or during the study period.
Receipt of any other vaccination within 30 days prior to the first R0.6C vaccination or planned vaccinations during the study period. Exceptions are made for vaccination against influenza and the novel coronavirus SARS-CoV2.
Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria (vaccine) study or CHMI.
Body weight > 115 kg
Being an employee or student of the department of Medical Microbiology of the Radboudumc at the time of screening, or a person otherwise related to the investigator.
Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew McCall, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university medical center | Nijmegen | Gelderland | 6525GA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38649867 | Result | Alkema M, Smit MJ, Marin-Mogollon C, Totte K, Teelen K, van Gemert GJ, van de Vegte-Bolmer M, Mordmuller BG, Reimer JM, Lovgren-Bengtsson KL, Sauerwein RW, Bousema T, Plieskatt J, Theisen M, Jore MM, McCall MBB. A Pfs48/45-based vaccine to block Plasmodium falciparum transmission: phase 1, open-label, clinical trial. BMC Med. 2024 Apr 23;22(1):170. doi: 10.1186/s12916-024-03379-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1A 30μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG001 | 1B 30μg R0.6C Alhydrogel + Matrix M1 | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG002 | 2A 30μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG003 | 2B 30μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG004 | 3A 100μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG005 | 3B 100μg R0.6C Alhydrogel + Matrix M1 | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG006 | 4A 100μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| FG007 | 4B 100μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1A 30μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Serious Adverse Events and Grade 3 Adverse Events | The number of serious adverse events and solicited and unsolicited grade 3 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization. | Posted | Number | adverse events | From first immunization up to 84 days after the last immunization |
|
Adverse events were recorded from baseline until 84 days after the fourth vaccination (252 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1A 30μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at injection site | Skin and subcutaneous tissue disorders | ICD-10 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew McCall | Radboud university medical center | +31 24 361 43 56 | Matthew.McCall@radboudumc.nl |
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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 14, 2021 | May 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2022 | May 4, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 15, 2021 | May 4, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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Study groups will be assigned sequentially to low and high doses of R0.6C Vaccine. Within each dose group, participants will be assigned randomly (1:1) to one of two adjuvant arms (either Alhydrogel alone or Alhydrogel + Matrix-M).
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| 3B 100μg R0.6C Alhydrogel + Matrix M1 | Experimental | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
|
| 4A 100μg R0.6C Alhydrogel | Experimental | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. |
|
| 4B 100μg R0.6C Alhydrogel + Matrix M1 | Experimental | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. |
|
| Transmission Reducing Activity |
The transmission reducing activity at other timepoint (I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84 sera by total number of oocysts in mosquitoes fed with I1-1 sera. |
| 14 days after immunization 1, 2 and 3. One day before immunization 4 and 84 days after immunization 4. |
| Anti-6C Antibody Quantities | The anti-6C antibody quantity in volunteer sera collected two weeks after fourth R0.6C immunization (I4+14) and at other time points (I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant combinations, as determined by ELISA. | 14 days after each immunization. One day before immunization 4 and 84 days after immunization 4. |
| BG001 |
| 1B 30μg R0.6C Alhydrogel + Matrix M1 |
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG002 | 2A 30μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG003 | 2B 30μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG004 | 3A 100μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG005 | 3B 100μg R0.6C Alhydrogel + Matrix M1 | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG006 | 4A 100μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG007 | 4B 100μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Median | Full Range | kg |
|
3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| OG002 | 2A 30μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| OG003 | 2B 30μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| OG004 | 3A 100μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| OG005 | 3B 100μg R0.6C Alhydrogel + Matrix M1 | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| OG006 | 4A 100μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
| OG007 | 4B 100μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. |
|
|
| Primary | Transmission Reducing Activity | The functional transmission reducing activity in the standard membrane feeding assay of volunteer sera collected two weeks after the fourth R0.6C immunization (I4+14), compared to baseline (I1-1) within each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I4+14 sera by total number of oocysts in mosquitoes fed with I1-1 sera. | Posted | Median | Full Range | % transmission reducing activity | 14 days after the fourth immunization |
|
|
|
| Secondary | Number of Grade 1 and 2 Adverse Events | The number of solicited and unsolicited grade 1 and 2 adverse events possibly, probably or definitely related to the vaccine in the period from first R0.6C administration up to 84 days after the last immunization. | Posted | Number | adverse events | From first immunization up to 84 days after the last immunization |
|
|
|
| Secondary | Transmission Reducing Activity | The transmission reducing activity at other timepoint (I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant groups. The TRA was calculated by dividing the total number of oocysts in mosquitoes fed with I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84 sera by total number of oocysts in mosquitoes fed with I1-1 sera. | TRA data were collected first for time points with highest antibody titres, if no significant TRA was detectable at these time points, TRA data was not collected for other timepoints. | Posted | Median | Full Range | % transmission reducing activity | 14 days after immunization 1, 2 and 3. One day before immunization 4 and 84 days after immunization 4. |
|
|
|
| Secondary | Anti-6C Antibody Quantities | The anti-6C antibody quantity in volunteer sera collected two weeks after fourth R0.6C immunization (I4+14) and at other time points (I1+14, I2+14, I3+14, I3+111 [I4-1], and I4+84) compared to baseline (I1-1) in each of the four dose-adjuvant combinations, as determined by ELISA. | One subject in group 2B withdrew consent 24 days after vaccination 4, therefore the I4+84 timepoint is only analyzed in 4 out of 5 subjects of group 2B. | Posted | Geometric Mean | 95% Confidence Interval | ug/mL | 14 days after each immunization. One day before immunization 4 and 84 days after immunization 4. |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 1B 30μg R0.6C Alhydrogel + Matrix M1 | 3 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | 2A 30μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | 2B 30μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 30 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG004 | 3A 100μg R0.6C Alhydrogel | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | 3B 100μg R0.6C Alhydrogel + Matrix M1 | 3 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG006 | 4A 100μg R0.6C Alhydrogel | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG007 | 4B 100μg R0.6C Alhydrogel + Matrix M1 | 5 subjects will receive four vaccinations of 100 ug R0.6C Alhydrogel + Matrix M1 on days 0, 28, 56 and 168. R0.6C transmission blocking vaccine: Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168. | 0 | 5 | 0 | 5 | 5 | 5 |
| Induration at injection site | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Itching at injection site | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Erythema at injection site | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Swelling at injection site | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Chills | General disorders | ICD-10 | Non-systematic Assessment |
|
| Fatigue | General disorders | ICD-10 | Non-systematic Assessment |
|
| Fever | General disorders | ICD-10 | Non-systematic Assessment |
|
| Headache | General disorders | ICD-10 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Tenderness at injection site | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | ICD-10 | Non-systematic Assessment |
|
| Drowsiness | General disorders | ICD-10 | Non-systematic Assessment |
|
| Elevated leukocytes | Blood and lymphatic system disorders | ICD-10 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ICD-10 | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | ICD-10 | Non-systematic Assessment |
|
| Tired sensation vaccinated upper arm | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | ICD-10 | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | ICD-10 | Non-systematic Assessment |
|
| Flushes | Endocrine disorders | ICD-10 | Non-systematic Assessment |
|
| Malaise | General disorders | ICD-10 | Non-systematic Assessment |
|
| Pain between shoulder blades | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Pain in armpit | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Pain hand | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Common cold | Infections and infestations | ICD-10 | Non-systematic Assessment |
|
| Herpes simplex infection | Infections and infestations | ICD-10 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | ICD-10 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | ICD-10 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | ICD-10 | Non-systematic Assessment |
|
| Hematoma after venipuncture | Injury, poisoning and procedural complications | ICD-10 | Non-systematic Assessment |
|
| Abdominal cramps | Gastrointestinal disorders | ICD-10 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | ICD-10 | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | ICD-10 | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | ICD-10 | Non-systematic Assessment |
|
| Pharyngitis | Gastrointestinal disorders | ICD-10 | Non-systematic Assessment |
|
| Spotting | Reproductive system and breast disorders | ICD-10 | Non-systematic Assessment |
|
| Trichomonas infection | Reproductive system and breast disorders | ICD-10 | Non-systematic Assessment |
|
| Cough | Infections and infestations | ICD-10 | Non-systematic Assessment |
|
| Cramp | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | ICD-10 | Non-systematic Assessment |
|
| Hangover | General disorders | ICD-10 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | ICD-10 | Non-systematic Assessment |
|
| Chalazion | Eye disorders | ICD-10 | Non-systematic Assessment |
|
| Cystitis | Renal and urinary disorders | ICD-10 | Non-systematic Assessment |
|
| Hay fever | Respiratory, thoracic and mediastinal disorders | ICD-10 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Otalgia | Ear and labyrinth disorders | ICD-10 | Non-systematic Assessment |
|
| Ankle sprain | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Thoracic pain | Musculoskeletal and connective tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | ICD-10 | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
| Lightheadedness | General disorders | ICD-10 | Non-systematic Assessment |
|
| Cut wound | Skin and subcutaneous tissue disorders | ICD-10 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D000079426 |
| Vector Borne Diseases |
|
| I1+14 |
|
| I2+14 |
|
| I3+111 [I4-1] |
|
| I4+84 |
|
|
| I1+14 |
|
|
| I2+14 |
|
|
| I3+14 |
|
|
| I4-1 |
|
|
| I4+14 |
|
|
| I4+84 |
|
|