A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment

NCT03307915 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR108372VAC89220HTX1002IPCAVD-013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability

  Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.

  7 days post-vaccination (approximately up to 37 weeks)

• Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability

  Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.

  7 days post-vaccination (approximately up to 37 weeks)

• Percentage of Participants With AEs as a Measure of Safety and Tolerability

  An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Approximately up to 96 weeks

Secondary Outcomes (6)

• Total IgG and Subclass Specific Antibody Titer

  Up to post-vaccination follow-up period until Week 96

• Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)

  Up to post-vaccination follow-up period until Week 96

• Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay

  Up to post-vaccination follow-up period until Week 96

• Functionality of T-cell Responses as Measured by ICS Assay

  Up to post-vaccination follow-up period until Week 96

• Phenotype of T-cell Responses as Measured by ICS Assay

  Up to post-vaccination follow-up period until Week 96

Study Arms (3)

Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo

EXPERIMENTAL

Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5\*10\^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10\^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections).

Biological: Ad26.Mos4.HIV; Biological: MVA-Mosaic; Drug: Placebo

Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140

EXPERIMENTAL

Participants will receive Ad26.Mos4.HIV, 5\*10\^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5\*10\^10 vp plus Clade C gp140 (125 microgram \[mcg\]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections).

Biological: Ad26.Mos4.HIV; Biological: Clade C gp140 + Mosaic gp140

Group 3: Placebo

PLACEBO COMPARATOR

Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections).

Drug: Placebo

Interventions

Ad26.Mos4.HIV BIOLOGICAL

Participants will receive Ad26.Mos4.HIV 5\*10\^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.

Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo; Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140

MVA-Mosaic BIOLOGICAL

Participants will receive MVA-Mosaic 10\^8 pfu as IM injection at Weeks 24 and 36.

Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo

Clade C gp140 + Mosaic gp140 BIOLOGICAL

Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.

Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140

Placebo DRUG

Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.

Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo; Group 3: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Each participant must have documented Human immunodeficiency virus type1 (HIV-1) infection
• Each participant must be on suppressive antiretroviral treatment (ART) for at least 48 weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability reasons only until 4 weeks prior to screening
• Each participant must have started ART outside of the acute or early phase of infection
• Each participant must have a plasma HIV ribonucleic acid (RNA) less than (\<) 50 copies/ milliliter (mL) at screening and at least one documented evidence of plasma HIV RNA \<50 copies/mL after the last ART change. In case of ART change within the 48 weeks prior randomization, at least one additional more recent documented plasma HIV RNA \<50 copies/mL is required. One blip of HIV RNA greater than (\>)50 and \<200 copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most recent (after last ART change, tested before and/or during screening) HIV RNA results are \<50 copies/mL
• Each participant must be medically stable as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening

You may not qualify if:

• Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study, or within 3 months after the last vaccination
• Anyone with contraindication to intramuscular injections and blood draws example, bleeding disorders
• Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0ºC (degree centigrade) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
• Anyone with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Anyone with a history of Acquired Immunodeficiency Syndrome (AIDS)-defining illness according to Centers for Disease Control and prevention (CDC) criteria based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with AIDS-defining illnesses assessed by the investigator as clinically irrelevant must be provided to the sponsor and Protocol Safety Review Team (PSRT), who will determine eligibility on a case-by-case basis prior to randomization
• Anyone with a history of CD4+ less than (\<) 200 cells per millimeter cube (cells/mm\^3), based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with history of CD4+ \<200 cells/mm\^3 assessed by the investigator as clinically irrelevant must be provided to the sponsor and PSRT, who will determine eligibility on a case-by-case basis prior to randomization
• Anyone who received or plans to receive: a) licensed live attenuated vaccines within 28 days before or after planned administration of any of the study vaccinations; b) other licensed (not live) vaccines - within 14 days before or after planned administration of any of the study vaccinations

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead
• Beth Israel Deaconess Medical Center: collaborator
• Ragon Institute of MGH, MIT and Harvard: collaborator
• US Military HIV Research Program: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 12, 2017
• Study Start: March 5, 2018
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

US (1)