Human Papilloma VirusPhase 3DoRISNCT02834637
A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls
A Phase 3 study testing bivalent HPV vaccine and nonavalent HPV vaccine in people with Human Papilloma Virus, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial summary
Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and mortality rates are very high. HPV vaccines are most effective if given to girls who have not yet acquired HPV infection. Read more about this study
- Who is it for?
- Ages 9 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- bivalent HPV vaccine and nonavalent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- 1 siteTanzania
- Study dates
- 23 Feb 2017to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and mortality rates are very high. HPV vaccines are most effective if given to girls who have not yet acquired HPV infection. In Tanzania, HPV vaccine has been shown to be safe, acceptable and can be delivered with high coverage (~80%). However, the cost of delivering HPV vaccine is considerably higher than costs for traditional infant/child vaccinations. This is primarily because of costs to establish outreach programmes and associated personnel costs including nurses who must spend significant time away from their posts to deliver vaccine, especially if multiple doses are needed. There is global interest in simplifying HPV vaccine delivery by reducing the number of doses. If a single dose could be given, this could halve the costs of delivery, making it more accessible to the populations that need it most. Recently, the WHO recommended that 2 doses of HPV vaccine could be given to young girls, based on studies in high and upper middle-income countries. However in Africa high rates of infections like malaria and worms can affect immune responses to vaccines. It is essential to know that reducing the number of doses does not reduce the protective immune response of these vaccines. The investigators are conducting a trial in Tanzanian girls aged 9-14 years to establish whether a single dose of HPV vaccine produces immune responses that are likely to be effective in preventing cervical cancer. Two different HPV vaccines, the bivalent (2-v) vaccine that protects against HPV 16/18 (the cause of 70% of cancers) and the 9-valent (9-v) vaccine that protects against 9 HPV types, will be compared. The trial will randomise 900 girls to 6 arms and follow them for 36 months. Girls will receive the 2-v or the 9-v HPV vaccine, as 1, 2 or 3 doses. Girls receiving 1 or 2 doses will be compared with those receiving 3 doses of the same vaccine, to ensure that the reduced dose regimen produces an immune response that is not inferior to 3 doses. Girls in the 1 and 2 dose arms will be enrolled in an extension and followed for up to 9 years, to examine the stability of immune responses. The immune responses in this study will also be compared with results from other countries where the vaccine has been shown to be protective. This will provide information about whether a reduced number of doses is likely to be protective in Africa. This work will be extremely important in informing future HPV vaccination strategies and will be one of the first randomised trials of 1 and 2 doses of any HPV vaccine in Africa.
Read the detailed description
Human papillomavirus (HPV) infection is the primary cause of cervical cancer, a major public health problem in Africa. Currently there are three vaccines (Cervarix, Gardasil® and Gardasil-9®) that offer excellent protection against HPV infection with vaccine-related HPV genotypes. The objective of this trial is to demonstrate non-inferiority of immune responses with 1 dose of HPV vaccine compared with the recommended 2 or 3 doses of the same vaccine by evaluating HPV 16/18-specific seropositivity, antibody avidity and memory B cell responses at M36. Specifically, the investigators will determine whether a single dose of the 2-valent HPV vaccine (Cervarix, that protects against HPV 16/18 genotypes) or of a new 9-valent HPV vaccine (Gardasil-9,that protects against HPV 6/11/16/18/31/33/45/52/58) produces immune responses that are non-inferior to those observed with 3 doses of vaccine when given to HIV-negative 9-14 years old girls in a malaria-endemic region of Tanzania.
The trial will also determine whether the World Health Organization's (WHO) recently recommended 2 dose strategy for girls aged under 15 years produces similar immune responses in Sub-Saharan Africa (SSA) compared to the previously recommended 3 dose schedule. In addition, the cost-effectiveness of alternative dosing schedules and of the two vaccines will be explored.
The trial will enrol 900 girls who are resident in Mwanza into an un-blinded, individually-randomised trial with 6 arms. Arm A will comprise participants randomised to receive 3 doses of the 2-valent vaccine, Arm B those randomised to receive 2 doses of the 2-valent vaccine and Arm C those randomised to receive 1 dose of the 2-valent vaccine. Arms D, E and F will be those participants randomised to receive 3, 2 or 1 dose of the 9-valent vaccine, respectively.
The effect of different dose schedules and type of HPV vaccine on a range of immune responses will be measured up to 36 months after the first dose. In a trial extension that will extend follow-up, we will also determine whether the one dose schedule of these vaccines produces non-inferior immune responses to the recommended two dose schedule for up to 108 months, and examine the long-term stability of the immune responses to 9 years after the first dose.
The protocol will be harmonised, and laboratory procedures and immunological endpoints will be cross-validated, with those of a large HPV vaccine dose-reduction efficacy trial being planned by the NIH in Costa Rica to examine the protective effect of the same vaccines given as 1 or 2 doses. This trial will allow the examination of quality and durability of antibody responses, and safety and cost-effectiveness of reduced dose schedules compared to the originally recommended 3 dose schedule in a population with high burden of malaria and other infections that may affect vaccine immune responses.
- Conditions
- Human Papilloma Virus
- Being tested
- bivalent HPV vaccine, nonavalent HPV vaccine
- Keywords
- HPV, cervical cancer, vaccines, HPV vaccine, dose reduction, Human papilloma virus vaccine schedules
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalent HPV vaccineDrug
Also called Cervarix
head to head comparisons of different dose schedules and HPV vaccine types
nonavalent HPV vaccineDrug
Also called Gardasil9
head to head comparisons of different dose schedules and HPV vaccine types
| Study group | Role | What they receive |
|---|---|---|
| 3 doses 2valent | Active comparator | 3 doses of bivalent HPV vaccine (Cervarix) given at M0, M1 and M6 Receives: Drug: bivalent HPV vaccine |
| 2 doses 2valent | Active comparator | 2 doses of bivalent HPV vaccine (Cervarix) given at M0 and M6 Receives: Drug: bivalent HPV vaccine |
| 1 dose 2valent | Active comparator | 1 dose of bivalent HPV vaccine (Cervarix) given at M0 Receives: Drug: bivalent HPV vaccine |
| 3 doses 9valent | Active comparator | 3 doses of nonavalent HPV vaccine (Gardasil9) given at M0, M2 and M6 Receives: Drug: nonavalent HPV vaccine |
| 2 doses 9valent | Active comparator | 2 doses of nonavalent HPV vaccine (Gardasil9) given at M0 and M6 Receives: Drug: nonavalent HPV vaccine |
| 1 dose 9valent | Active comparator | 1 dose of nonavalent HPV vaccine (Gardasil9) given at M0 Receives: Drug: nonavalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-inferiority of antibody seropositivity of 1 dose compared with 2 or 3 doses of the same vaccine
Proportion with HPV 16/18-specific seropositivity
Measured: Month 24
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
Geometric mean HPV 16/18 titre
Measured: Month 24
non-inferiority of antibody seropositivity of 1 dose compared with 2 doses of the same vaccine
Proportion with HPV 16/18-specific seropositivity
Measured: Month 60 and Month 108
Secondary outcomes (14)
non-inferiority of HPV 16/18 seropositivity after 1 dose compared with 2 or 3 doses of the same vaccine
Proportion with HPV 16/18-specific seropositivity
Measured: Month 12 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.
HPV 16/18-specific seropositivity and antibody GMT
Measured: Month 7, Month 12, Month 24 and Month 36
equivalence of HPV 16/18 seropositivity and antibody GMT at all time points when comparing the same dose regimen between the 2 vaccine types
HPV 16/18-specific seropositivity and antibody GMT
Measured: 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
HPV 16/18-specific antibody avidity and memory B cell responses
Measured: Month 12, Month 24, Month 36, Month 84 and Month 108 (avidity); Month 12, Month 24 and Month 36 (memory B cells)
stability of antibody responses when comparing within the same arm.
HPV 16/18-specific antibody GMT
Measured: Month 36, Month 60 and M108
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
HPV 16/18-specific seropositivity
Measured: Month 24
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
HPV 16/18-specific seropositivity
Measured: Month 24
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
HPV 16/18-specific antibody GMT
Measured: Month 24
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
HPV 6/11/31/33/45/52/58-specific antibody seropositivity
Measured: Month 12, Month 24 and Month 36
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
HPV 6/11/31/33/45/52/58-specific antibody GMT
Measured: Month 12, Month 24 and Month 36
unit cost of 1 dose regimens compared with 2 and 3 dose regimens
incremental financial and economic costs of vaccination, using WHO costing tool
Measured: up to Month 36
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
estimates of costs and effects of vaccination will be integrated into an existing HPV cost-effectiveness model (WHO CHOICE)
Measured: up to Month 36
number of participants with treatment related solicited adverse events
solicited adverse events considered to have a reasonable possibility of having been contributed to by the vaccine
Measured: within 30 days after each dose
number of participants with treatment related unsolicited adverse events
unsolicited adverse events considered to have a reasonable possibility of having been contributed to by the vaccine
Measured: up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start23 Feb 2017
- Primary completion15 Jan 2020
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, Institut Català d'Oncologia, National Cancer Institute (NCI), Karolinska Institutet, Technische Universität Berlin, National Institute for Medical Research, Tanzania, University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Deborah Watson-Jones, Dr, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834637
- Sponsor's protocol ID
- MITU-002
- Acronym
- DoRIS
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2016
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baisley K, Kemp TJ, Kreimer AR, Basu P, Changalucha J, Hildesheim A, Porras C, Whitworth H, Herrero R, Lacey CJ, Schiller JT, Lucas E, Mutani P, Dillner J, Indangasi J, Muwonge R, Hayes RJ, Pinto LA, Watson-Jones D. Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose of HPV vaccine in historical cohorts: an immunobridging analysis of a randomised controlled trial. Lancet Glob Health. 2022 Oct;10(10):e1485-e1493. doi: 10.1016/S2214-109X(22)00306-0.
PubMed 36113532Baisley KJ, Whitworth HS, Changalucha J, Pinto L, Dillner J, Kapiga S, de Sanjose S, Mayaud P, Hayes RJ, Lacey CJ, Watson-Jones D. A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) - Study protocol for a randomised controlled trial. Contemp Clin Trials. 2021 Feb;101:106266. doi: 10.1016/j.cct.2021.106266. Epub 2021 Jan 6.
PubMed 33421649Watson-Jones D, Changalucha J, Whitworth H, Pinto L, Mutani P, Indangasi J, Kemp T, Hashim R, Kamala B, Wiggins R, Songoro T, Connor N, Mbwanji G, Pavon MA, Lowe B, Mmbando D, Kapiga S, Mayaud P, de SanJose S, Dillner J, Hayes RJ, Lacey CJ, Baisley K. Immunogenicity and safety of one-dose human papillomavirus vaccine compared with two or three doses in Tanzanian girls (DoRIS): an open-label, randomised, non-inferiority trial. Lancet Glob Health. 2022 Oct;10(10):e1473-e1484. doi: 10.1016/S2214-109X(22)00309-6.
PubMed 36113531Watson-Jones D, Changalucha J, Maxwell C, Whitworth H, Mutani P, Kemp TJ, Kamala B, Indangasi J, Constantine G, Hashim R, Mwanzalima D, Wiggins R, Mmbando D, Connor N, Pavon MA, Lowe B, Kapiga S, Mayaud P, de Sanjose S, Dillner J, Hayes RJ, Lacey CJ, Pinto L, Baisley K. Durability of immunogenicity at 5 years after a single dose of human papillomavirus vaccine compared with two doses in Tanzanian girls aged 9-14 years: results of the long-term extension of the DoRIS randomised trial. Lancet Glob Health. 2025 Feb;13(2):e319-e328. doi: 10.1016/S2214-109X(24)00477-7.
PubMed 39890232Baisley K, Kemp TJ, Mugo NR, Whitworth H, Onono MA, Njoroge B, Indangasi J, Bukusi EA, Prabhu PR, Mutani P, Galloway DA, Mwanzalime D, Kapiga S, Lacey CJ, Hayes RJ, Changalucha J, Pinto LA, Barnabas RV, Watson-Jones D. Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose in young women aged 15-20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials. Lancet Glob Health. 2024 Mar;12(3):e491-e499. doi: 10.1016/S2214-109X(23)00586-7.
PubMed 38365419Whitworth HS, Beshir KB, Baisley KJ, Mbwanji G, Indangasi J, Kemp T, Kamala B, Maxwell C, Hashim R, Mukerebe C, Mayaud P, Lowe B, Gabriel N, Connor N, Kapiga S, De Sanjose S, Lacey CJ, Hayes RJ, Pinto L, Changalucha J, Sutherland CJ, Watson-Jones D. Effect of malaria parasitaemia on antibody responses to single-dose and two-dose HPV vaccination: results from the DoRIS dose-reduction immunogenicity trial in Tanzanian girls. Vaccine. 2026 Jun 30;89:128889. doi: 10.1016/j.vaccine.2026.128889. Online ahead of print.
PubMed 42378813Kemp TJ, Baisley K, Changalucha J, Indangasi J, Whitworth H, Lacey CJ, Mwanzalima D, Hashim R, Kapiga S, Hayes RJ, Pinto LA, Watson-Jones D. Immunogenicity of one and two doses of Gardasil(R)9 in Tanzanian girls in the DoRIS Trial. NPJ Vaccines. 2025 Dec 19;11(1):22. doi: 10.1038/s41541-025-01344-1.
PubMed 41419735Hsiao A, Struckmann V, Stephani V, Mmbando D, Changalucha J, Baisley K, Levin A, Morgan W, Hutubessy R, Watson-Jones D, Whitworth H, Quentin W. Costs of delivering human papillomavirus vaccination using a one- or two-dose strategy in Tanzania. Vaccine. 2023 Jan 9;41(2):372-379. doi: 10.1016/j.vaccine.2022.11.032. Epub 2022 Nov 29.
PubMed 36460537
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls
- ClinicalTrials.gov ID
- NCT02834637
- Acronym / sponsor ID
- DoRIS / MITU-002
- Conditions
- Human Papilloma Virus
- Keywords
- HPV, cervical cancer, vaccines, HPV vaccine, dose reduction, Human papilloma virus vaccine schedules
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 930 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of York, Institut Català d'Oncologia, National Cancer Institute (NCI), Karolinska Institutet, Technische Universität Berlin, National Institute for Medical Research, Tanzania, University of Glasgow
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical cancer is the most common cancer in women aged 15-44 years in East Africa, and mortality rates are very high. HPV vaccines are most effective if given to girls who have not yet acquired HPV infection. In Tanzania, HPV vaccine has been shown to be safe, acceptable and can be delivered with high coverage (~80%). However, the cost of delivering HPV vaccine is considerably higher than costs for traditional infant/child vaccinations. This is primarily because of costs to establish outreach programmes and associated personnel costs including nurses who must spend significant time away from their posts to deliver vaccine, especially if multiple doses are needed. There is global interest in simplifying HPV vaccine delivery by reducing the number of doses. If a single dose could be given, this could halve the costs of delivery, making it more accessible to the populations that need it most. Recently, the WHO recommended that 2 doses of HPV vaccine could be given to young girls, based on studies in high and upper middle-income countries. However in Africa high rates of infections like malaria and worms can affect immune responses to vaccines. It is essential to know that reducing the number of doses does not reduce the protective immune response of these vaccines. The investigators are conducting a trial in Tanzanian girls aged 9-14 years to establish whether a single dose of HPV vaccine produces immune responses that are likely to be effective in preventing cervical cancer. Two different HPV vaccines, the bivalent (2-v) vaccine that protects against HPV 16/18 (the cause of 70% of cancers) and the 9-valent (9-v) vaccine that protects against 9 HPV types, will be compared. The trial will randomise 900 girls to 6 arms and follow them for 36 months. Girls will receive the 2-v or the 9-v HPV vaccine, as 1, 2 or 3 doses. Girls receiving 1 or 2 doses will be compared with those receiving 3 doses of the same vaccine, to ensure that the reduced dose regimen produces an immune response that is not inferior to 3 doses. Girls in the 1 and 2 dose arms will be enrolled in an extension and followed for up to 9 years, to examine the stability of immune responses. The immune responses in this study will also be compared with results from other countries where the vaccine has been shown to be protective. This will provide information about whether a reduced number of doses is likely to be protective in Africa. This work will be extremely important in informing future HPV vaccination strategies and will be one of the first randomised trials of 1 and 2 doses of any HPV vaccine in Africa.
Detailed description
Human papillomavirus (HPV) infection is the primary cause of cervical cancer, a major public health problem in Africa. Currently there are three vaccines (Cervarix, Gardasil® and Gardasil-9®) that offer excellent protection against HPV infection with vaccine-related HPV genotypes. The objective of this trial is to demonstrate non-inferiority of immune responses with 1 dose of HPV vaccine compared with the recommended 2 or 3 doses of the same vaccine by evaluating HPV 16/18-specific seropositivity, antibody avidity and memory B cell responses at M36. Specifically, the investigators will determine whether a single dose of the 2-valent HPV vaccine (Cervarix, that protects against HPV 16/18 genotypes) or of a new 9-valent HPV vaccine (Gardasil-9,that protects against HPV 6/11/16/18/31/33/45/52/58) produces immune responses that are non-inferior to those observed with 3 doses of vaccine when given to HIV-negative 9-14 years old girls in a malaria-endemic region of Tanzania.
The trial will also determine whether the World Health Organization's (WHO) recently recommended 2 dose strategy for girls aged under 15 years produces similar immune responses in Sub-Saharan Africa (SSA) compared to the previously recommended 3 dose schedule. In addition, the cost-effectiveness of alternative dosing schedules and of the two vaccines will be explored.
The trial will enrol 900 girls who are resident in Mwanza into an un-blinded, individually-randomised trial with 6 arms. Arm A will comprise participants randomised to receive 3 doses of the 2-valent vaccine, Arm B those randomised to receive 2 doses of the 2-valent vaccine and Arm C those randomised to receive 1 dose of the 2-valent vaccine. Arms D, E and F will be those participants randomised to receive 3, 2 or 1 dose of the 9-valent vaccine, respectively.
The effect of different dose schedules and type of HPV vaccine on a range of immune responses will be measured up to 36 months after the first dose. In a trial extension that will extend follow-up, we will also determine whether the one dose schedule of these vaccines produces non-inferior immune responses to the recommended two dose schedule for up to 108 months, and examine the long-term stability of the immune responses to 9 years after the first dose.
The protocol will be harmonised, and laboratory procedures and immunological endpoints will be cross-validated, with those of a large HPV vaccine dose-reduction efficacy trial being planned by the NIH in Costa Rica to examine the protective effect of the same vaccines given as 1 or 2 doses. This trial will allow the examination of quality and durability of antibody responses, and safety and cost-effectiveness of reduced dose schedules compared to the originally recommended 3 dose schedule in a population with high burden of malaria and other infections that may affect vaccine immune responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 3 doses 2valent | Active comparator | Drug: bivalent HPV vaccine3 doses of bivalent HPV vaccine (Cervarix) given at M0, M1 and M6 |
| 2 doses 2valent | Active comparator | Drug: bivalent HPV vaccine2 doses of bivalent HPV vaccine (Cervarix) given at M0 and M6 |
| 1 dose 2valent | Active comparator | Drug: bivalent HPV vaccine1 dose of bivalent HPV vaccine (Cervarix) given at M0 |
| 3 doses 9valent | Active comparator | Drug: nonavalent HPV vaccine3 doses of nonavalent HPV vaccine (Gardasil9) given at M0, M2 and M6 |
| 2 doses 9valent | Active comparator | Drug: nonavalent HPV vaccine2 doses of nonavalent HPV vaccine (Gardasil9) given at M0 and M6 |
| 1 dose 9valent | Active comparator | Drug: nonavalent HPV vaccine1 dose of nonavalent HPV vaccine (Gardasil9) given at M0 |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- They are diagnosed with chronic conditions, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bivalent HPV vaccineAlso: Cervarixhead to head comparisons of different dose schedules and HPV vaccine types | Drug | 1 dose 2valent, 2 doses 2valent, 3 doses 2valent |
| nonavalent HPV vaccineAlso: Gardasil9head to head comparisons of different dose schedules and HPV vaccine types | Drug | 1 dose 9valent, 2 doses 9valent, 3 doses 9valent |
Primary outcome
non-inferiority of antibody seropositivity of 1 dose compared with 2 or 3 doses of the same vaccine
Time frame: Month 24
Proportion with HPV 16/18-specific seropositivity
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
Geometric mean HPV 16/18 titre
non-inferiority of antibody seropositivity of 1 dose compared with 2 doses of the same vaccine
Time frame: Month 60 and Month 108
Proportion with HPV 16/18-specific seropositivity
14 secondary outcomes
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
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
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)
stability of antibody responses when comparing within the same arm.
Time frame: Month 36, Month 60 and M108
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 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
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
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 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
unit cost of 1 dose regimens compared with 2 and 3 dose regimens
Time frame: up to Month 36
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
number of participants with treatment related solicited adverse events
Time frame: within 30 days after each dose
number of participants with treatment related unsolicited adverse events
Time frame: up to Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Results publication: PubMed 36113532Baisley K, Kemp TJ, Kreimer AR, Basu P, Changalucha J, Hildesheim A, Porras C, Whitworth H, Herrero R, Lacey CJ, Schiller JT, Lucas E, Mutani P, Dillner J, Indangasi J, Muwonge R, Hayes RJ, Pinto LA, Watson-Jones D. Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose of HPV vaccine in historical cohorts: an immunobridging analysis of a randomised controlled trial. Lancet Glob Health. 2022 Oct;10(10):e1485-e1493. doi: 10.1016/S2214-109X(22)00306-0.
- Results publication: PubMed 33421649Baisley KJ, Whitworth HS, Changalucha J, Pinto L, Dillner J, Kapiga S, de Sanjose S, Mayaud P, Hayes RJ, Lacey CJ, Watson-Jones D. A dose-reduction HPV vaccine immunobridging trial of two HPV vaccines among adolescent girls in Tanzania (the DoRIS trial) - Study protocol for a randomised controlled trial. Contemp Clin Trials. 2021 Feb;101:106266. doi: 10.1016/j.cct.2021.106266. Epub 2021 Jan 6.
- Results publication: PubMed 36113531Watson-Jones D, Changalucha J, Whitworth H, Pinto L, Mutani P, Indangasi J, Kemp T, Hashim R, Kamala B, Wiggins R, Songoro T, Connor N, Mbwanji G, Pavon MA, Lowe B, Mmbando D, Kapiga S, Mayaud P, de SanJose S, Dillner J, Hayes RJ, Lacey CJ, Baisley K. Immunogenicity and safety of one-dose human papillomavirus vaccine compared with two or three doses in Tanzanian girls (DoRIS): an open-label, randomised, non-inferiority trial. Lancet Glob Health. 2022 Oct;10(10):e1473-e1484. doi: 10.1016/S2214-109X(22)00309-6.
- Results publication: PubMed 39890232Watson-Jones D, Changalucha J, Maxwell C, Whitworth H, Mutani P, Kemp TJ, Kamala B, Indangasi J, Constantine G, Hashim R, Mwanzalima D, Wiggins R, Mmbando D, Connor N, Pavon MA, Lowe B, Kapiga S, Mayaud P, de Sanjose S, Dillner J, Hayes RJ, Lacey CJ, Pinto L, Baisley K. Durability of immunogenicity at 5 years after a single dose of human papillomavirus vaccine compared with two doses in Tanzanian girls aged 9-14 years: results of the long-term extension of the DoRIS randomised trial. Lancet Glob Health. 2025 Feb;13(2):e319-e328. doi: 10.1016/S2214-109X(24)00477-7.
- Results publication: PubMed 38365419Baisley K, Kemp TJ, Mugo NR, Whitworth H, Onono MA, Njoroge B, Indangasi J, Bukusi EA, Prabhu PR, Mutani P, Galloway DA, Mwanzalime D, Kapiga S, Lacey CJ, Hayes RJ, Changalucha J, Pinto LA, Barnabas RV, Watson-Jones D. Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose in young women aged 15-20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials. Lancet Glob Health. 2024 Mar;12(3):e491-e499. doi: 10.1016/S2214-109X(23)00586-7.
- Derived from this study: PubMed 42378813Whitworth HS, Beshir KB, Baisley KJ, Mbwanji G, Indangasi J, Kemp T, Kamala B, Maxwell C, Hashim R, Mukerebe C, Mayaud P, Lowe B, Gabriel N, Connor N, Kapiga S, De Sanjose S, Lacey CJ, Hayes RJ, Pinto L, Changalucha J, Sutherland CJ, Watson-Jones D. Effect of malaria parasitaemia on antibody responses to single-dose and two-dose HPV vaccination: results from the DoRIS dose-reduction immunogenicity trial in Tanzanian girls. Vaccine. 2026 Jun 30;89:128889. doi: 10.1016/j.vaccine.2026.128889. Online ahead of print.
- Derived from this study: PubMed 41419735Kemp TJ, Baisley K, Changalucha J, Indangasi J, Whitworth H, Lacey CJ, Mwanzalima D, Hashim R, Kapiga S, Hayes RJ, Pinto LA, Watson-Jones D. Immunogenicity of one and two doses of Gardasil(R)9 in Tanzanian girls in the DoRIS Trial. NPJ Vaccines. 2025 Dec 19;11(1):22. doi: 10.1038/s41541-025-01344-1.
- Derived from this study: PubMed 36460537Hsiao A, Struckmann V, Stephani V, Mmbando D, Changalucha J, Baisley K, Levin A, Morgan W, Hutubessy R, Watson-Jones D, Whitworth H, Quentin W. Costs of delivering human papillomavirus vaccination using a one- or two-dose strategy in Tanzania. Vaccine. 2023 Jan 9;41(2):372-379. doi: 10.1016/j.vaccine.2022.11.032. Epub 2022 Nov 29.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Watson-Jones, Dr principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bivalent HPV vaccine and nonavalent HPV vaccine in people with Human Papilloma Virus, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-inferiority of antibody seropositivity of 1 dose compared with 2 or 3 doses of the same vaccine (time frame: Month 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02834637, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.