Trial Outcomes & Findings for A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines (NCT NCT04586673)
NCT ID: NCT04586673
Last Updated: 2025-04-29
Results Overview
• Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
140 days
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
3 participants received one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
10 participants received one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
10
|
|
Overall Study
COMPLETED
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines
Baseline characteristics by cohort
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
n=3 Participants
3 participants received one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
n=10 Participants
10 participants received one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38 years
n=5 Participants
|
30 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, White British
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 140 days• Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.
Outcome measures
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
n=3 Participants
3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
n=10 Participants
10 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
|---|---|---|
|
Assessement of Safety
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 28 days after each vaccinationProportion of volunteers with Grade 3 or 4 unsolicited adverse events (AEs) through 28 days post final vaccination
Outcome measures
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
n=3 Participants
3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
n=10 Participants
10 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
|---|---|---|
|
Assement of Safety
|
0 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: up to day 7Population: All volunteers were included in the analysis, and all experienced at least one solicited AE after vaccination
Proportion of volunteers with local and systemic reactogenicity events from Day 0 to Day 6 post vaccination
Outcome measures
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
n=3 Participants
3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
n=10 Participants
10 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
|---|---|---|
|
Assessment of Safety
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 5 monthsThe proportion of participants that develop T-cell responses to tHIVconsvx measured by IFN-gamma ELISpot assay
Outcome measures
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
n=3 Participants
3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
n=10 Participants
10 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
|---|---|---|
|
Assessment of the Immunogenicity of the ChAdOx1.tHIVconsv1 and MVA.tHIVconsv3 & 4 Vaccines Administered Sequentially.
|
3 Participants
|
10 Participants
|
Adverse Events
ChAdOx1.tHIVconsv1 Low Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ChADOx1.tHIVconsv1 Higher Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ChAdOx1.tHIVconsv1 Low Dose
n=3 participants at risk
3 participants received one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^9 vp
|
ChADOx1.tHIVconsv1 Higher Dose
n=10 participants at risk
10 participants received one dose of ChAdOx1.tHIVconsv1 at 5 x 10\^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10\^8 pfu and MVA.tHIVconsv4 at 0.9 x 10\^8 pfu.
ChAdOx1.tHIVconsv1 (C1): ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 (M3): MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 (M4): MVA.tHIVconsv4 09. x 10\^8 pfu
|
|---|---|---|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
100.0%
10/10 • Number of events 19 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
20.0%
2/10 • Number of events 2 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Cardiac disorders
palpitations
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Gastrointestinal disorders
gastric pain
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Gastrointestinal disorders
Loss of appetite
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Blood and lymphatic system disorders
lymphopenia
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
20.0%
2/10 • Number of events 2 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Skin and subcutaneous tissue disorders
warmth at injection site
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
60.0%
6/10 • Number of events 7 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Skin and subcutaneous tissue disorders
redness at injection site
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
60.0%
6/10 • Number of events 10 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Skin and subcutaneous tissue disorders
pain at injection site
|
33.3%
1/3 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
90.0%
9/10 • Number of events 17 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Skin and subcutaneous tissue disorders
itch in injection site
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
10.0%
1/10 • Number of events 2 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
General disorders
fever
|
0.00%
0/3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
20.0%
2/10 • Number of events 3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
General disorders
arthralgia
|
33.3%
1/3 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
80.0%
8/10 • Number of events 10 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
General disorders
myalgia
|
33.3%
1/3 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
100.0%
10/10 • Number of events 16 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
General disorders
feverishness
|
66.7%
2/3 • Number of events 2 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
90.0%
9/10 • Number of events 13 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
General disorders
Headache
|
100.0%
3/3 • Number of events 3 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
100.0%
10/10 • Number of events 16 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
70.0%
7/10 • Number of events 12 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
|
General disorders
Malaise
|
66.7%
2/3 • Number of events 2 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
100.0%
10/10 • Number of events 15 • Study visits for safety evaluations occurred 1, 7, 14 and 28 days after each vaccination, with additional visits up to days 112 and 140 in Groups 1 and 2, respectively. Safety data included specified, solicited symptoms, collected up to day 7 after each vaccination; unsolicited AEs, collected up to day 28 after each vaccination; and SAEs collected until the end of the study. Blood samples for the evaluation of biochemical and/or haematological parameters were taken at selected study visits.
The severity of clinical and laboratory AEs was assessed according to the scales in the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (Corrected Version 2.1, Jul 2017).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place