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NCT02685020
Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
Phase 1 trial testing Ad26.Mos.HIV in Healthy in 36 participants. Completed in 3 January 2019.
5 January 2018
Quick facts
| Lead sponsor | Janssen Vaccines & Prevention B.V. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 28 March 2016 |
| Primary completion | 5 January 2018 |
| Estimated completion | 3 January 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ad26.Mos.HIV — full drug profile →
- Clade C gp140 — full drug profile →
- Placebo
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Janssen Vaccines & Prevention B.V. — full company profile →
Who can join
Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Progress in HIV vaccine development.
Hsu DC, O'Connell RJ. · · 2017 · cited 62× · PMID 28281871 · DOI 10.1080/21645515.2016.1276138 -
Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment.
Custers J, Kim D, Leyssen M, Gurwith M, et al · · 2021 · cited 59× · PMID 33676782 · DOI 10.1016/j.vaccine.2020.09.018 -
New concepts in HIV-1 vaccine development.
Stephenson KE, D'Couto HT, Barouch DH. · · 2016 · cited 58× · PMID 27268856 · DOI 10.1016/j.coi.2016.05.011 -
Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).
Stephenson KE, Wegmann F, Tomaka F, Walsh SR, et al · · 2020 · cited 21× · PMID 32078815 · DOI 10.1016/s2352-3018(20)30001-1 -
The Question of HIV Vaccine: Why Is a Solution Not Yet Available?
Libera M, Caputo V, Laterza G, Moudoud L, et al · · 2024 · cited 9× · PMID 38628675 · DOI 10.1155/2024/2147912
Verify or expand the search:
- PubMed search for NCT02685020
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ad26.Mos.HIV
Trials testing the same drug.
- NCT02788045 — Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad2 · Phase 1, PHASE2 · completed
- NCT02315703 — Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mo · Phase 1, PHASE2 · completed
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Other Janssen Vaccines & Prevention B.V. trials
Trials by the same sponsor.
- NCT05901636 — A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults · Phase 1, PHASE2 · completed
- NCT05327816 — A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Year · Phase 1, PHASE2 · terminated
- NCT05091307 — A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults · Phase 3 · completed
- NCT05101486 — A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years · Phase 3 · completed
- NCT05083585 — A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Ag · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02685020 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Vaccines & Prevention B.V.
- Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02685020.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing