Phase 2
Completed N=27
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
Source: ClinicalTrials.gov NCT02919306 ↗Enrolled (actual)
27
Serious AEs
3.9%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs) — 0; 0 percentage of participants
Summary
The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26 (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on suppressive antiretroviral therapy (ART) that was initiated during acute Human Immunodeficiency Virus (HIV) infection; 2) Measure the frequency and duration of sustained viremic control after receiving Ad26 prime/MVA boost or placebo, defined as greater than 24 weeks with plasma HIV ribonucleic acid (RNA) lesser than (<)50 copies/ml after antiretroviral (ARV) analytical treatment interruption (ATI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Grade 3 or 4 Solicited Local Adverse Events (AEs) |
0; 0 | — |
| PRIMARY Percentage of Participants With Grade 3 or 4 Solicited Systemic AEs |
0; 0 | — |
| PRIMARY Percentage of Participants With Grade 3 or 4 Unsolicited AEs |
0; 0 | — |
| PRIMARY Percentage of Participants With Grade 3 or 4 Related AEs |
0; 0 | — |
| PRIMARY Percentage of Participants With Solicited Local AEs for 7 Days After Each Vaccination |
88.2; 66.7 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs for 7 Days After Each Vaccination |
70.6; 55.6 | — |
| PRIMARY Percentage of Participants With Unsolicited AEs 28 Days After Each Vaccination |
88.2; 77.8 | — |
| PRIMARY Percentage of Participants With Related AEs and Serious Adverse Events (SAEs) |
29.4; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With AEs Leading to Discontinuation of Study Vaccination |
0; 0 | — |
| PRIMARY Percentage of Participants With AEs |
88.2; 77.8 | — |
| PRIMARY Percentage of Participants With Worst Laboratory Toxicity Grades 1, 2, 3, and 4 and Non-graded Serum Chemistry Abnormalities |
50; 50; 50; 50; 12.5; 12.5 | — |
| PRIMARY Percentage of Participants With Worst Laboratory Toxicity Grade 1 and Non-graded Hematology Abnormalities |
0; 12.5; 11.8; 0; 5.9; 11.1 | — |
| PRIMARY Percentage of Participants With Sustained Viremic Control (Human Immunodeficiency Virus [HIV] Ribonucleic Acid [RNA] Less Than [<]50 Copies Per Milliliter [Copies/mL]) During ATI Phase |
0; 11.1 | — |
| PRIMARY Duration of Sustained Viremic Control With HIV RNA <50 Copies/mL During ATI Phase |
27.7 | — |
| SECONDARY Total HIV Deoxyribonucleic Acid (DNA) Levels Over Time |
34.83; 80.10; 47.24; 80.00 | — |
| SECONDARY Change in Cluster of Differentiation (CD)4 Count Over Time |
637; 531; 602; 498; 661; 618 | — |
| SECONDARY Time to Reinitiating ART |
5.4; 4.5 | — |
| SECONDARY Number of Participants With Acute Retroviral Syndrome Post-ARV ATI |
0; 0 | — |
| SECONDARY Duration of Acute Retroviral Syndrome Post-ARV ATI |
NA; NA | — |
| SECONDARY Percentage of Participants With HIV Resistance to ARV Drugs Who Experienced Rebound Viremia After ARV ATI |
35.3; 22.2 | — |
| SECONDARY Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot) at Week 24, 26, 48, and 50 |
70.6; 11.1; 100; 22.2; 70.6; 22.2 | — |
| SECONDARY Percentage of Responders for Envelop (Env) Clade A, B, C and Mos1-specific Binding Antibody Titers |
100; 11.1; 100; 0; 94.1; 11.1 | — |
| SECONDARY Percentage of Responders for Clade C (C97ZA.012) Env ELISA Immunoglobulin G1 (IgG1), IgG2, and IgG3 Glycoprotein (gp) 140 Binding Antibody |
68.8; 0; 0; 18.8; 11.1 | — |
| SECONDARY Breadth of T Cell Responses Analyzed by ELISPOT Assays |
2.0; 3.5; 10.0; 3.0; 8.0; 3.0 | — |
| SECONDARY Percentage of Env Antibody-dependent Cellular Phagocytosis (ADCP) Glycoprotein (gp) Antibody Over Time |
4.500; 0; 18.200; 0; 10.500; 0 | — |
| SECONDARY Percentage of Responders for HIV Neutralizing Antibody (nAb) |
100; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed human immunodeficiency virus (HIV)-1 infected and started antiretroviral therapy (ART) during acute infection (Fiebig stages I, II, III or IV) as part of trial RV254
- Treatment with current stable antiretroviral therapy (ART) (no changes to treatment) for at least 4 weeks prior to screening
- All female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin) at the screening visit, and a negative urine pregnancy test prior to vaccination on Day 1 and prior to subsequent study vaccinations
- HIV ribonucleic acid (RNA) less than ( )50 and =11 gram/deciliter (g/dL); Men >=12.5 g/dL, b) White cell count: 2,500 to 11,000 cells per cubic millimeter (cells/mm^3), c) Platelets: 125,000 to 450,000 per mm^3, d) Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to 400 cells/mm^3, g) Troponin 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulation hormone [FSH] level >40 International Units Per Liter (IU/L); surgically sterile; or b) Of child-bearing potential and practicing an effective double method of birth control (example, prescription oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch, or vaginal ring, in conjunction with either a female condom or one of the methods for male contraception before entry and through 3 months after the last vaccination
Exclusion Criteria
- Receipt of any vaccine within 30 days prior to the first vaccination or plans to receive within 30 days post-vaccination. In the case of medically indicated vaccines, the vaccination should be given at least 2 weeks before or after the first vaccination. However, if a vaccine is indicated in a post exposure setting (example, rabies or tetanus), it must take priority over the study vaccine and same rules will apply to subsequent study vaccinations
- Any history of HIV-related illness under Centers for Disease Control and Prevention (CDC) category C
- History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
- Chronic active hepatitis B or active hepatitis C (for example, positive serology with confirmatory positive polymerase chain reaction) or active syphilis infection. Active syphilis documented by examination or serology unless positive serology is due to past treated infection
- Receipt of blood products or immunoglobulin in the past 3 months
- History of anaphylaxis or other serious adverse reactions to vaccines or vaccine products, or neomycin or streptomycin or egg products
- History of chronic urticaria (recurrent hives)
- Chronic or recurrent use of medications which modify host immune response, example (e.g.) cancer chemotherapeutic agents, parenteral corticosteroids (short course oral steroids given for non-chronic conditions not expected to recur is not an exclusion criteria, topical steroid use is not an exclusion criteria), etc. but not including ART
Data sourced from ClinicalTrials.gov (NCT02919306). 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. Informational only — not medical advice.