A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT02834637
• Date of registration: 29/06/2016
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls DoRIS
• Scientific title: A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls
• Date of first enrolment: February 23, 2017
• Target sample size: 930
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02834637
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Tanzania

Contacts

• Name: Deborah Watson-Jones, Dr
• Affiliation: London School of Hygiene and Tropical Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Born female;

- Aged between 9 and 14 years inclusive;

- Enrolled in a government primary or secondary day school in Mwanza city (or
neighbouring district if included);

- Living in Mwanza city (or neighbouring district if included) without plans to move
away in the next 36 months;

- Willing to participate in the study and sign the informed assent form;

- Supported in this study participation by at least one of their parents (or LAR), who
has signed the informed consent document;

- In good health as determined by a medical history (a physical examination will be
conducted if necessary according to the clinician's judgement); and

- Able to pass a Test of Understanding (TOU) if aged 12 years or above, or if younger
than 12 years old, a parent or LAR is able to pass a TOU

Exclusion Criteria:

- They are diagnosed with chronic conditions, such as autoimmune conditions,
degenerative diseases, neurologic or genetic diseases among others;

- They are HIV positive, or immunocompromised;

- They are pregnant, less than three months post-partum or currently breastfeeding;

- They are allergic to one of the vaccine components or to latex;

- They are sexually active and are not willing to use an effective birth control
method from 28 days before the first dose until 60 days after the last vaccine
dose;

- The nurse or clinician determining the eligibility, in agreement with principal
investigator, considers that there is a reason that precludes participation;

- They have been previously vaccinated against HPV



Age minimum: 9 Years
Age maximum: 14 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Human Papilloma Virus

Intervention(s)

Drug: nonavalent HPV vaccine

Drug: bivalent HPV vaccine

Primary Outcome(s)

non-inferiority of antibody geometric mean titre (GMT) of 1 dose of either vaccine compared with historical cohorts of women who received 1 dose in whom efficacy has been demonstrated [Time Frame: Month 24]

non-inferiority of antibody seropositivity of 1 dose compared with 2 doses of the same vaccine [Time Frame: Month 60 and Month 108]

non-inferiority of antibody seropositivity of 1 dose compared with 2 or 3 doses of the same vaccine [Time Frame: Month 24]

Secondary Outcome(s)

equivalence of HPV 16/18 seropositivity and antibody GMT at all time points when comparing the same dose regimen between the 2 vaccine types [Time Frame: Month 12, Month 24, Month 36, Month 60, Month 84 and Month 108]

evaluate HPV 16/18 antibody avidity and memory B cell responses at all time points, comparing different dose regimens of the same vaccine and the same dose regimen between the two vaccines [Time Frame: Month 12, Month 24, Month 36, Month 84 and Month 108 (avidity); Month 12, Month 24 and Month 36 (memory B cells)]

evaluate HPV 6/11/31/33/45/52/58 antibody seropositivity with the 1 and 2 dose regimens of the 9-valent vaccine compared with the 3-dose regimen [Time Frame: Month 12, Month 24 and Month 36]

evaluate HPV 16/18 seropositivity and antibody GMT at all time points when comparing 2 doses with 3 doses of the same vaccine. [Time Frame: Month 7, Month 12, Month 24 and Month 36]

evaluate HPV 16/18 seropositivity when comparing 1 dose of either vaccine with historical cohorts of women who received 1, 2 or 3 doses, in whom efficacy has been demonstrated [Time Frame: Month 24]

evaluate HPV 6/11/31/33/45/52/58 antibody GMT with the 1 and 2 dose regimens of the 9-valent vaccine compared with the 3-dose regimen [Time Frame: Month 12, Month 24 and Month 36]

non-inferiority of HPV 16/18 antibody GMT when comparing the 2 dose regimen of either vaccine with historical cohorts of women who received 3 doses, in whom efficacy has been demonstrated [Time Frame: Month 24]

number of participants with treatment related unsolicited adverse events [Time Frame: up to Month 36]

evaluate HPV 16/18 seropositivity when comparing the 2 dose regimen of either vaccine with historical cohorts of women who received 3 doses, in whom efficacy has been demonstrated [Time Frame: Month 24]

cost-effectiveness of 1 dose regimens compared with 2 and 3 dose regimens, and of the 9-valent vaccine compared with the 2-valent vaccine [Time Frame: up to Month 36]

non-inferiority of HPV 16/18 seropositivity after 1 dose compared with 2 or 3 doses of the same vaccine [Time Frame: Month 12 and Month 36]

unit cost of 1 dose regimens compared with 2 and 3 dose regimens [Time Frame: up to Month 36]

number of participants with treatment related solicited adverse events [Time Frame: within 30 days after each dose]

stability of antibody responses when comparing within the same arm. [Time Frame: Month 36, Month 60 and M108]

Secondary ID(s)

MITU-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institut Català d'Oncologia

Tanzanian National Institute for Medical Research

University of York

Karolinska Institutet

Technische Universität Berlin

National Cancer Institute (NCI)

University of Glasgow