Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Vaccine-Preventable Diseases

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Immunologic Factors

Single dose of the 4-valent HPV vaccine (Gardasil®; Merck \& Co.) offered to all eligible boys aged 14 to 18 years in the 13 intervention communities. Girls aged 14 years are offered 2 doses of Gardasil® through the Tanzanian national HPV vaccine programme

Girls aged 14 years are offered 2 doses of Gardasil® through the Tanzanian national HPV vaccine programme

Single dose 4-valent HPV vaccine in males. Gardasil®, manufactured by MSD, consists of a licensed prophylactic virus-like particle (VLP) vaccine that protects against 4 HPV genotypes (HPV 6, 11, 16, 18).

Gardasil® HPV vaccine

Add-Vacc is an unblinded cluster-randomised trial (CRT) with two arms: (i) the national HPV vaccination programme (girls aged \~14 years, control arm) and (ii) the national programme plus single-dose male HPV vaccination given to a multi-year cohort of boys (intervention arm). The CRT will be conducted in 26 communities/clusters (13 per arm) in northern Tanzania. Boys aged 14 to 18 years in the intervention arm will receive one dose of the 4-valent HPV vaccine (Gardasil®) that protects against HPV 6, 11, 16, and 18. Population genital HPV prevalence in 18 to 21-year-olds will be compared between intervention clusters (female and male vaccination) and control clusters (female vaccination only) at 3 years after the intervention. Blood sampling for immune responses and adverse event data collection will be performed in a subset of 200 male subjects in selected intervention clusters.

Cluster randomised trial with 26 communities (13 per arm)

Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania

Prevalence of 4-valent vaccine HPV genotype DNA (HPV 6, 11, 16 or 18) in males and females aged 18 to 21 years in intervention clusters and control clusters 36 months post-male vaccination

Proportion seroconverting to, and geometric mean antibody titres (GMTs) for, HPV vaccine genotypes, and safety and tolerability (local and systemic adverse events), measured in a subset of 200 vaccinated boys

The proportion of females, and of males, aged 18 to 21 years in the control arm with detectable genital 4-valent HPV vaccine genotype DNA at baseline and at M36.

The proportion of females aged 16 years who received 1 dose of HPV vaccine (uptake) and who complete 2 doses (coverage) by arm at baseline and M36

Self-reported acceptability of and barriers to receiving male vaccination by community members and to delivering male HPV vaccination by health care workers (HCW)

Incremental cost-effectiveness ratio for single dose male vaccination plus existing female vaccination programme compared to female vaccination only

Mwanza Intervention Trials Unit, National Institute for Medical Research

York Biomedical Research Institute, Hull York Medical School, University of York

Cancer Epidemiology Research Programme Institut Català d' Oncologia

Karolinska Institute Department of Laboratory Medicine

Department of Pathology University of Cambridge

London School of Hygiene and Tropical Medicine

Neoplasms

Uterine Cervical Neoplasms

Patients who have been vaccinated against HPV virus.

Patients who have not been vaccinated against HPV virus.

Philippe MERVIEL, PU-PH

Each year in France, more than 6000 new cases of HPV inducted cancers are recorded. The vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. Therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed.

HPVAC2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up HPV vaccination.

Women from 25 years old and born after 1984 may be included if they come to the Brest CHU to do their regular cervical smear. At this time, a survey will be given to know their vaccinal status.

The aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.

Impact of Catch-up HPV Vaccination

Impact of Catch-up HPV Vaccination on the Development of Cervical Lesions

Study the effectiveness of anti-HPV vaccine (done between 15 and 19 years old).

Study the effectiveness of anti-HPV vaccine (done between 11 and 15 years old).

Study the effectiveness of anti-HPV vaccine (not regarding the period of realization)

Compare the effectiveness of anti-HPV vaccine done before and after 15 years old.

Study the impact of the known cervical cancer risk factors on the smear results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania	NCT04953130	HPV Infection Vaccine Prevent...	Gardasil® HPV v...	14 Years - 18 Years	London School of Hygiene and Tropical Medicine
Impact of Catch-up HPV Vaccination	NCT05462249	HPV HPV Vaccination Vaccine Prevent... Cervical Lesion Cervical Cancer		25 Years - 38 Years	University Hospital, Brest
Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania	NCT04953130	HPV Infection Vaccine Prevent...	Gardasil® HPV v...	14 Years - 18 Years	London School of Hygiene and Tropical Medicine
Impact of Catch-up HPV Vaccination	NCT05462249	HPV HPV Vaccination Vaccine Prevent... Cervical Lesion Cervical Cancer		25 Years - 38 Years	University Hospital, Brest

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