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Adding Male Single Dose HPV Vaccination to Female HPV Vaccination in Tanzania (Add-Vacc)

Primary Purpose

HPV Infection, Vaccine Preventable Disease

Status

Active

Phase

Phase 4

Locations

Tanzania

Study Type

Interventional

Intervention

Gardasil® HPV vaccine

About this trial

This is an interventional prevention trial for HPV Infection

Eligibility Criteria

14 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.
Participants must agree to avoid all non-trial immunisations in the 14 days following vaccination with the trial vaccine, other than emergency vaccinations such as post-exposure rabies or tetanus vaccinations.
Participants must be healthy as determined by a medical history. A physical examination will be conducted if necessary according to the clinician's judgement.

Exclusion Criteria:

Boys will be excluded from HPV vaccination if:

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;
There are significant conditions or clinically significant findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., it would compromise their safety or well-being).

Sites / Locations

Mwanza Intervention Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Male vaccination + national HPV vaccination programme

National HPV vaccination programme only

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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

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)

Cost-effectiveness of adding a multi-year single dose male HPV vaccination strategy to the national female HPV vaccination programme

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

Full Information

NCT ID

NCT04953130

First Posted

June 28, 2021

Last Updated

October 4, 2023

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04953130

Brief Title

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

Acronym

Add-Vacc

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HPV Infection, Vaccine Preventable Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Cluster randomised trial with 26 communities (13 per arm)

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

10400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Male vaccination + national HPV vaccination programme

Arm Type

Experimental

Arm Description

Arm Title

National HPV vaccination programme only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Gardasil® HPV vaccine

Other Intervention Name(s)

4-valent HPV vaccine

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

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 36

Secondary Outcome Measure Information:

Title

Immunogenicity and safety of single dose 4-valent HPV vaccination in boys

Description

Time Frame

Month 12, 24 and 36

Title

Impact of female-only vaccination through the national vaccination programme on population HPV prevalence in 18 to 21-year-old males and females

Description

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 36

Title

Uptake of dose 1 and coverage of dose 2 in eligible target groups for the national HPV vaccination programme;

Description

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 36

Title

Acceptability of a gender-neutral approach to HPV vaccination

Description

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 24

Title

Cost-effectiveness of adding a multi-year single dose male HPV vaccination strategy to the national female HPV vaccination programme

Description

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

Time Frame

Month 36

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Participants must agree to avoid all non-trial immunisations in the 14 days following vaccination with the trial vaccine, other than emergency vaccinations such as post-exposure rabies or tetanus vaccinations. Participants must be healthy as determined by a medical history. A physical examination will be conducted if necessary according to the clinician's judgement. Exclusion Criteria: Boys will be excluded from HPV vaccination if: 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; There are significant conditions or clinically significant findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., it would compromise their safety or well-being).

Facility Information:

Facility Name

Mwanza Intervention Trials Unit

City

Mwanza

Country

Tanzania

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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