A Phase 2 interventional study of HPV vaccine and Placebo in HPV Vaccine, sponsored by International Vaccine Institute. Recruiting at 1 site in Ghana. Open to participants aged 9 Months to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by International Vaccine Institute · Phase 2, Interventional, and Prevention
This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.
Cervical cancer is a significant public health problem in Africa and a leading cause of cancer deaths in women. According to the WHO, Africa has the highest cervical cancer disease incidence and associated mortality in the world accounting for 19% of all global cases of cervical cancer and 23% of all cervical cancer related deaths. The high-risk Human Papillomavirus (HPV) Types16 and 18 are responsible for 70% of all global cervical cancers with a high prevalence of 22% in sub-Saharan Africa compared to a prevalence of 12%globally. The bivalent Cecolin HPV vaccine, manufactured by Innovax of China, has demonstrated >95% efficacy against HPV16/18 infections in women aged 18 to 26 years and some protection against HPV 31, 33 and 45. The hypothesis of this trial is that infants/toddlers vaccinated with the bivalent Cecolin will show similar safety, tolerability, and immunogenicity as compared to that observed in older age groups, 15 to 20year old, where efficacy has been established.
This trial is a proof-of-concept study to descriptively compare the safety, tolerability, and immunogenicity of HPV vaccination in a pediatric population. The aim is to demonstrate safety and tolerability, and that short-term immune responses in infants and toddlers are comparable to the responses in older girls and women between 15-20 years, an age group in whom efficacy has been shown. If the vaccines are shown to be safe, well tolerated, and sufficiently immunogenic in this pilot study, this would provide evidence to support larger statistically robust studies to test the safety, immunogenicity, longevity of immune response, and acceptability of including HPV vaccines in the routine EPI.
A total of one hundred and fifteen (N=115) eligible participants will be enrolled in the study with an age de-escalation approach for the pediatric cohort. First, the safety cohort of 15 children between the age of 2-5 years will be randomized in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). To progress enrolment of toddlers aged 15 months, the DSMB will review safety data of the preceding safety cohort (2-5 years old) collected in the first week (until D7 visit) of follow-up according to pre-specified halting criteria. If halting criteria are not met, a further 15 toddlers (15 months) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 toddlers, there will be a second safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 15-month-old cohort will continue recruitment. Following confirmation by the DSMB, 15 infants (9 months old) will be recruited similarly in a 3:2 ratio to receive HPV (n=9) and placebo (n=6). After the recruitment of the first 15 of 35 infants, there will be another safety review by the DSMB. If halting criteria are not met, the remaining 20 participants of the 9-month-old cohort will continue recruitment. The safety cohort and the toddlers will receive either a single dose of the HPV vaccine or placebo while the 9-month-old will either receive two doses of the HPV vaccine 6 months apart or the placebo. Adolescent girls and young women aged between 15 and 20 year olds will be recruited in open label study in parallel.
International Vaccine Institute is the lead sponsor of 47 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HPV Vaccine
Biological: HPV vaccine
Placebo
Biological: Placebo
HPV Vaccine
Biological: HPV vaccine · Biological: Measles and rubella Vaccine
Placebo
Biological: Placebo · Biological: Measles and rubella Vaccine
HPV + MR Vaccine
Biological: HPV vaccine · Biological: Measles and rubella Vaccine
Placebo + MR Vaccine
Biological: Placebo · Biological: Measles and rubella Vaccine
HPV Vaccine (Open Label)
Biological: HPV vaccine
0.5 mL HPV Vaccine Injection Intramuscular
0.5 mL Placebo injection intramuscular
Drug pages: Measles Vaccine · Rubella Vaccine
Measles and rubella Vaccine according to EPI
Safety and Reactogenicity of HPV Vaccination
Occurrence of solicited and unsolicited adverse events following single-dose or two-dose HPV vaccination administered concomitantly with routine Expanded Programme on Immunization (EPI) vaccines, including Measles and Rubella (MR) vaccine, among infants aged 9 months, toddlers aged 15 months, and children aged 2-5 years. Results will be summarized as the number of participants experiencing adverse events
Time frame: 9 months post vaccination
HPV16/18 VLP ELISA Antibody Titers
HPV16 and HPV18 antibody levels measured using Virus-Like Particle (VLP) Enzyme-Linked Immunosorbent Assay (ELISA) in serum samples collected from participants who received one or two doses of HPV vaccine. Antibody levels are expressed as ELISA antibody titers (IU/mL).
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
Geometric Mean Concentration of HPV16/18 Antibodies
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA in vaccinated participants, expressed as IU/mL.
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
HPV16/18 Seroconversion Rate
Seroconversion rate of HPV16 and HPV18 antibodies measured using VLP ELISA, defined as the proportion of participants who change from seronegative at baseline to seropositive after HPV vaccination. Results are expressed as a percentage of participants
Time frame: 1 month and 7 months post HPV vaccination
HPV16/18 VLP ELISA Antibody Titers by Age and Sex
HPV16 and HPV18 antibody titers measured using VLP ELISA among male and female infants and toddlers aged 9 and 15 months and children aged 2-5 years following HPV vaccination, expressed as ELISA antibody titers (IU/mL).
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
Geometric Mean Concentration of HPV16/18 Antibodies by Age Group
Geometric mean concentration (GMC) of HPV16 and HPV18 antibodies measured using VLP ELISA among infants, toddlers, and children receiving HPV vaccination, expressed as IU/mL.
Time frame: At 1, 7, 12, and 24 months post-HPV vaccination
Measles and Rubella Seroconversion Rate
Seroconversion rate of Measles and Rubella antibodies measured one month after MR vaccination among 9- and 15-month-old infants and toddlers who received MR vaccine with or without concomitant HPV vaccination. Results are expressed as a percentage of participants.
Time frame: 1 month post MR vaccination
HPV16/18 Neutralizing Antibody Titers (PBNA)
Neutralizing antibody titers against HPV16 and HPV18 measured using a pseudovirion-based neutralization assay (PBNA) in participants who received one or two doses of HPV vaccine. Results are expressed as neutralizing antibody titers.
Time frame: Baseline, 1, 7, 12, and 24 months post HPV vaccination
Geometric Mean Concentration of HPV16/18 Neutralizing Antibodies
Geometric mean concentration of neutralizing antibodies against HPV16 and HPV18 measured using PBNA, expressed as geometric mean neutralizing antibody titers.
Time frame: Baseline, 1, 7, 12, and 24 months post HPV vaccination
Acceptability of HPV Vaccination in Infants and Toddlers
Acceptability of HPV vaccination in infants and toddlers as reported by parents or caregivers and healthcare workers using structured questionnaires, summarized using questionnaire scores
Time frame: Up to 7 months post vaccination
Plan to share: No
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Studies of the drugs tested here: Measles Vaccine · Rubella Vaccine
International Vaccine Institute