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NCT04265950: OPTIMO
Establishing Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV, OPTIMO Trial
Phase 4 trial testing Recombinant Human Papillomavirus Nonavalent Vaccine in HIV Infection in 97 participants. Participants enrolled and being followed up; not accepting new ones.
30 June 2026
Quick facts
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 97 |
| Start date | 10 March 2022 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 3 locations across Haiti, Brazil, Peru |
Drugs / interventions tested
- Recombinant Human Papillomavirus Nonavalent Vaccine — full drug profile →
Conditions studied
- HIV Infection — all drugs for HIV Infection →
Sponsor
Fred Hutchinson Cancer Center — full company profile →
Who can join
Adults 9 to 13, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase IV trial compares 3 different dosing schedules to find the optimal number of doses for HPV vaccination in children and adolescents living with HIV. Comparing 3 different dosing schedules may help researchers determine whether a single dose of HPV vaccine could be effective in preventing HPV in children and adolescents living with HIV.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Framework for Cervical Cancer Elimination in Low-and-Middle-Income Countries: A Scoping Review and Roadmap for Interventions and Research Priorities.
Shin MB, Liu G, Mugo N, Garcia PJ, et al · · 2021 · cited 43× · PMID 34277540 · DOI 10.3389/fpubh.2021.670032 -
State-of-the-Science of human papillomavirus vaccination in women with human immunodeficiency Virus: Summary of a scientific workshop.
Schuind AE, Rees H, Schiller J, Mugo N, et al · · 2023 · cited 3× · PMID 37576844 · DOI 10.1016/j.pmedr.2023.102331 -
ULACNet-301, OPTIMO protocol: optimizing HPV vaccination regimen for cancer prevention in children and adolescents living with HIV.
Pinto-Santini D, Jalil EM, Fernandes GT, Hilaire G, et al · · 2025 · cited 1× · PMID 39871186 · DOI 10.1186/s12885-025-13551-z
Verify or expand the search:
- PubMed search for NCT04265950
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Recombinant Human Papillomavirus Nonavalent Vaccine
Trials testing the same drug.
- NCT05985681 — Testing RG1-VLP Vaccine to Prevent HPV-related Cancers · Phase 1 · recruiting
- NCT05237947 — Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO · Phase 4 · active not recruiting
- NCT03284866 — HPV Vaccine Therapy in Reducing High-Grade Cervical Lesions in Patients With HIV and HPV · Phase 3 · completed
- NCT03180034 — Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESC · Phase 4 · active not recruiting
- NCT03051516 — HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Phase 4 · terminated
Other recruiting trials for HIV Infection
Currently open trials in the same condition.
- NCT06900829 — #AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-i · NA · recruiting
- NCT06908252 — MAPS PrEP Van Study · Phase 4 · recruiting
- NCT07042945 — MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003) · Phase 1 · recruiting
- NCT06716450 — Multiplo Tp/HIV Self-Test · NA · recruiting
- NCT07086989 — Cardiovascular Risk in Children With Chronic Conditions Study · recruiting
Other Fred Hutchinson Cancer Center trials
Trials by the same sponsor.
- NCT07390968 — Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Pati · Phase 2 · not yet recruiting
- NCT07493252 — A Behavioral Application for Improving Smoking Cessation Among Smokers · NA · not yet recruiting
- NCT07490860 — A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to · NA · not yet recruiting
- NCT07194980 — Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small L · Phase 2 · not yet recruiting
- NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S · NA · not yet recruiting
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 NCT04265950 (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 Fred Hutchinson Cancer Center
- Last refreshed: 6 October 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/NCT04265950.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing