A Phase 1 interventional study of Ad26.Mos.HIV and Clade C gp140 in Healthy, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Vaccines & Prevention B.V. · Phase 1, Interventional, and Prevention
The primary purpose of this study is to assess safety, tolerability of the different vaccine schedules (different regimen durations and different number of dose administrations) with Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody (Ab) responses of the different vaccine schedules.
This is a phase 1 single-center, randomized (the study drug is assigned by chance), parallel group (each group of participants will be treated at the same time), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. Participants will be randomized in to 3 groups and will receive study vaccines or placebo. Group 1 will have 4 vaccination time points during 48 weeks, Groups 2 and 3 will have 3 vaccination time points during 24 weeks. The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (maximum 48 weeks), and a Follow-up Period (up to 72 weeks). Participants' safety will be monitored throughout the study. An optional Long-term Extension (LTE) phase (approximately 1 year after Week 72) will be performed for participants randomized to receive study vaccine, who have received all planned vaccinations and are negative for HIV infection at Week 72. The duration of the participation will be approximately 124 weeks for participants participating to the optional LTE phase.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 36 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Janssen Vaccines & Prevention B.V. is the lead sponsor of 48 studies on the registry; none are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 32 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Biological: Ad26.Mos.HIV · Biological: Clade C gp140
Participants will receive placebo at weeks 0, 12, 24 and 48.
Drug: Placebo
Participants will receive Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 0, 12 and 24.
Biological: Ad26.Mos.HIV · Biological: Clade C gp140
Participants will receive placebo at weeks 0, 12 and 24.
Drug: Placebo
Participants will receive Ad26.Mos.HIV vaccine at Week 0; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 8 and 24.
Biological: Ad26.Mos.HIV · Biological: Clade C gp140
Participants will receive placebo at weeks 0, 8 and 24.
Drug: Placebo
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
The Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Normal saline, 0.5 mL injection administered intramuscularly.
Titer to HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay
Time frame: Up to Week 72
Breadth of HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay
Time frame: Up to Week 72
Number of Participants With Local and Systemic Reactogenicity for 8 Days After Each Vaccination
Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema or swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 8 days post-vaccination. These occurrences will be recorded through the diary card provided to serve as a reminder to the participants for the next clinic visit.
Time frame: Up to 8 days after each vaccination
Treatment Emergent Adverse Events (AEs)
Time frame: Up to Week 72
Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
Time frame: Up to Week 124
Discontinuations From Vaccination or From Study due to AEs
Time frame: At the time of discontinuation from vaccination or from study (Up to Week 72)
Number of Participants With AEs or SAEs
Time frame: Up to 28 days after each vaccination
Env-Specific Functional Antibodies: Phagocytosis Score
Time frame: Up to Week 72
Env-Specific Functional Antibodies: Breadths
Time frame: Up to Week 72
Env-Specific Binding Antibody Isotypes: Titers
The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody titers will be assessed using ELISA.
Time frame: Up to Week 72
Env-Specific Binding Antibody Isotypes: Breadths
The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody breadths will be assessed using ELISA.
Time frame: Up to Week 72
Env-Specific Neutralizing Antibodies (nAbs): Titers
Time frame: Up to Week 72
Env-Specific Neutralizing Antibodies (nAbs): Breadths
Time frame: Up to Week 72
Induction of New T-cell Immune Response by the Vaccine
Induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay) measuring Spot forming Units per 1 million peripheral blood mononuclear cells (SFU/1 mio PBMCs) above threshold (\> 50 sfu/mio PBMC).
Time frame: Up to Week 72
Change From Baseline of the Frequency of HIV-Specific PBMC and/or CD4 and/or CD8 T cells as Measured by ELISpot Interferon (IFN) Gamma
Time frame: Up to Week 72
Mucosal Immunogenicity
Immune Responses to the Different Vaccine Schedules in Mucosal Secretions.
Time frame: Up to week 72
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
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