This trial is active, not recruiting.

Condition condylomata acuminata
Treatments low dosage hpv vaccine, medium dosage hpv vaccine, high dosage hpv vaccine, aluminium adjuvant
Phase phase 1
Sponsor Jun Zhang
Collaborator Xiamen Innovax Biotech Co., Ltd
Start date March 2015
End date September 2016
Trial size 144 participants
Trial identifier NCT02405520, HPV-PRO-004


This phase I clinical study was designed to evaluate the safety and immunogenicity of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers will receive the 3 different formulations of the novel HPV vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Participants in this arm would receive low dosage of HPV vaccines.
low dosage hpv vaccine
Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
Participants in this arm would receive medium dosage of HPV vaccines.
medium dosage hpv vaccine
Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
Participants in this arm would receive high dosage of HPV vaccines.
high dosage hpv vaccine
Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
(Placebo Comparator)
Participants in this arm would receive placebo (Aluminium Adjuvant).
aluminium adjuvant
Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.

Primary Outcomes

Measure adverse reactions/events throughout the study
time frame: 10 month

Secondary Outcomes

Measure anti-HPV 6/11 antibody in serum samples at 7 month to evaluate the immunogenicity of the HPV 6/11 vaccine formulations.
time frame: 7 month

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion criteria: 1. Females aged between 18 and 55 years. 2. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations. 3. Written informed consent obtained from the participants. 4. Able to comply with the requests of the study. 5. Axillary temperature not higher than 37.0°C 6. Nonpregnancy verified by a urine pregnancy test. Exclusion criteria: 1. Pregnant or breastfeeding or plan to be pregnant within 7 months. 2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period. 3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment. 4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine. 5. Administration of any attenuated live vaccines within 30 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination. 6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination. 7. Having the plan to participate another clinical trial during the study period. 8. Received another HPV vaccine. 9. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response). 10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain. 11. Having serious disease of internal medicine, such as hypertension, cardiac disease, diabetes, hyperthyroidism et al. 12. Asthma that required emergent treatment, hospitalization, oral or intravenous corticosteroid for unstable condition within the past 2 years. 13. Diagnosed coagulant function abnormality (i.e., clotting factors absent, clotting hemorrhagic disease, abnormal platelet function) or blood coagulation disorder. 14. Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3 years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3 years. 15. Past or current two-stage affective psychosis, not well controlled in the past 2 years or requiring drugs, or h a tendency to commit suicide. 16. Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual's ability to obey the protocol or sign the informed consent.

Additional Information

Official title A Phase I Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years
Principal investigator Zhao-Jun Mo, Master
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Xiamen University.