Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age14-18
SponsorLondon School of Hygiene and Tropical Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parents and adult male participants (aged 18 years) must sign an ICF and male participants aged less than 18 years must sign an informed assent form (IAF), indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to receive HPV vaccination. If the parent or participant cannot read or write, the procedures must be explained and informed consent/assent must be witnessed by a literate third party who is not involved in the conduct of the study.
Participants must have been born male, and must be aged 14 to 18 years inclusive at time of vaccination.
Participants must be living in an intervention community (cluster).
Participants must be willing and able to comply with the protocol requirements.
Disqualifiers
They have previously been vaccinated against HPV.
They have a history of allergy or anaphylaxis to one or more of the HPV vaccine components, to yeast or to latex.
They are enrolled in another vaccine research study that specifically specifies that they must not participate in a study of another vaccine
They have been diagnosed with a chronic condition (except HIV, as per the comment above), such as an autoimmune condition, sickle cell disease, degenerative disease, neurologic or genetic disease, among others;
Trial design
Design model
Parallel
Treatments tested in this trial
Gardasil® HPV vaccine
Biological/VaccineSingle 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).
Treatment groups
10,400 Participants
are divided into 2 treatment groupsGroup A: Male vaccination + national HPV vaccination programmeExperimental treatment 1 intervention
Group B: National HPV vaccination programme onlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Impact of adding single-dose male HPV vaccination to the national HPV vaccination programme in girls on population 4-valent HPV genotype prevalence in 18 to 21-year-old females and males
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
Time frame
Month 36Secondary outcomes
1
Immunogenicity and safety of single dose 4-valent HPV vaccination in boys
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
Time frame
Month 12, 24 and 362
Impact of female-only vaccination through the national vaccination programme on population HPV prevalence in 18 to 21-year-old males and females
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.
Time frame
Month 363
Uptake of dose 1 and coverage of dose 2 in eligible target groups for the national HPV vaccination programme;
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
Time frame
Month 364
Acceptability of a gender-neutral approach to HPV vaccination
Self-reported acceptability of and barriers to receiving male vaccination by community members and to delivering male HPV vaccination by health care workers (HCW)
Time frame
Month 24Sponsors and contacts
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London School of Hygiene and Tropical Medicine
Lead sponsor
Mwanza Intervention Trials Unit, National Institute for Medical Research
Collaborator
York Biomedical Research Institute, Hull York Medical School, University of York
Collaborator
Cancer Epidemiology Research Programme Institut Català d' Oncologia
Collaborator
Karolinska Institute Department of Laboratory Medicine
Collaborator
University of Cambridge
Collaborator
Source ClinicalTrials.gov