Phase 2
N=393
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02315703 ↗Enrolled (actual)
393
Serious AEs
8.6%
Results posted
Nov 2020
Primary outcome: Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination — 88.0; 83.7; 75.5; 77.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ad26.Mos.HIV (Biological); MVA-Mosaic (Biological); gp140 DP Low-dose (Biological); gp140 DP High-dose (Biological); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination |
88.0; 83.7; 75.5; 77.1; 77.6; 77.6 | — |
| PRIMARY Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination |
88.0; 85.7; 73.5; 75.0; 87.8; 73.5 | — |
| PRIMARY Percentage of Participants With Unsolicited Adverse Events Post Vaccination |
80.0; 73.5; 85.7; 87.5; 69.4; 83.7 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) Post Vaccination |
5; 2; 3; 4; 4; 5 | — |
| PRIMARY Percentage of Responders for Envelop (Env) Clade A, B and C-specific Binding Antibody Titers at Week 28 |
100.0; 97.6; 97.8; 95.5; 97.7; 97.6 | — |
| SECONDARY Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody |
78.7; 80.5; 50.0; 82.2; 61.9; 67.5 | — |
| SECONDARY Percentage of Responders for Env ELISA Including Consensus C and Mos1 Antigens |
100; 100.0; 100.0; 95.5; 100.0; 100.0 | — |
| SECONDARY Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody |
20.0; 20.0; 10.0; 66.7; 0; 0 | — |
| SECONDARY Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) |
54.2; 41.5; 21.7; 51.1; 43.2; 36.6 | — |
| SECONDARY Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody |
76.6; 95.8; 94.6; 76.1; 90.9; 97.6 | — |
| SECONDARY Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot) |
91.5; 79.5; 75.0; 95.5; 97.7; 92.1 | — |
Summary
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.
Eligibility Criteria
Inclusion Criteria
- Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG) and laboratory criteria, and vital signs measurement performed at Screening
- Participants are negative for human immunodeficiency virus (HIV) infection at Screening
- All female participants of childbearing potential must have a negative serum (beta human chorionic gonadotropin) at Screening, and a negative urine pregnancy test pre-dose on Week 0, 12, 24, and 48
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine
- Participants are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria
- Participant has chronic active hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- In the 12 months prior to enrollment, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- Participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
- Participant has had major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
- Participant has had a thyroidectomy, or thyroid disease requiring medication during the last 12 months
- Participant has a history of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow up)
- Participant has an ECG (per examination and interpretation of a cardiologist) with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, including any of the following: a) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS >=120 millisecond [ms], PR interval >=220 ms, any 2nd or 3rd degree AV block, or QTc prolongation [>450 ms]); b) significant repolarization (ST segment or T wave) abnormality; c) significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy (for example frequent premature atrial contractions, 2 premature ventricular contractions in a row); d) ST elevation consistent with ischemia, or evidence of past or evolving myocardial infarction
- Participant has a history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, or neomycin or streptomycin or egg products
Data sourced from ClinicalTrials.gov (NCT02315703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.