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To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years

ConditionsHPV InfectionHPV-Related CarcinomaHPV-Related Intraepithelial NeoplasiaGenital Wart
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-45
SponsorShanghai Bovax Biotechnology Co., Ltd.

About this trial

To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants aged 9-45；

Participants aged 18-45 who can provide legal identification，participants aged 9-17 and their guardian can provide legal identification；

Participants and/or their guardian sign an informed consent form;

Axillary temperature less than 37.3 ℃（>14 years old）or less than 37.5℃（≤14 years old）at the time of enrollment；

Disqualifiers

Have been vaccinated with other HPV vaccines or planned to vaccinate other HPV vaccines during the study period；

Plan to participate other clinical trials during the study period，or participated other clinical trials （including vaccine or drug）and received medication or vaccine within 3 months before enrollment ,

History of positive HPV testing (including types not covered by the trial vaccine) among the participants aged 18-45 years old;

History of CIN2/AIS/Cervical Cancer/Pelvic radiation therapy in female participants;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medium dose for 15-HPV vaccine

    Biological/Vaccine

    Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

  • High dose for 15-HPV vaccine

    Biological/Vaccine

    Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

  • Placebo

    Biological/Vaccine

    Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

  • 9-HPV vaccine

    Biological/Vaccine

    Participants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule

Treatment groups

330 Participants
are divided into 4 treatment groups
Group A: Medium dose for 15-HPV vaccineExperimental treatment 1 intervention
Group B: High dose for 15-HPV vaccineExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Group D: 9-HPV-vaccineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Adverse Events

AE of local and systemic reactions within 30 minutes after each dose

Time frame
Up to 30 minutes after any vaccination
2

Percentage of Participants With Solicited Adverse Events

The percentage of participants with one or more solicited AEs was assessed.

Time frame
Up to 14 days after any vaccination
3

Percentage of Participants With Unsolicited Adverse Events

Percentage of Participants With Unsolicited Adverse Events

Time frame
Up to 30 days after any vaccination
4

Percentage of Participants With Serious Adverse Events

The percentage of participants with one or more SAEs was assessed

Time frame
From Day 0 after the first dose of vaccination to 6 months after the thrid dose

Secondary outcomes

1

Immunogenicity after receiving 3 doses of 15-HPV vaccine

Geometric mean titer (GMT) of anti-vaccine containing corresponding type of neutralizing antibody in subjects aged 18-45 years on the 31-day after the third dose of immunization

Time frame
Up to 31 days after the third vaccination
2

Immunogenicity of 15-HPV vaccine

Seroconversion rate （SCR）of the anti-vaccine containing the corresponding type of neutralizing antibody on day 31 after total immunization in subjects aged 18-45 years

Time frame
Up to 31 days after the third vaccination
3

Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants

Geometric Mean Fold Increase (GMI) and 4-fold increase rates of anti-vaccine corresponding types of neutralizing antibodies in baseline seropositive subjects aged 18-45 years at day 31 after immunization

Time frame
Up to 31 days after the third vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Bovax Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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