Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine

Condylomata Acuminata Clinical Trial

Official title:

A PhaseⅡ Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Immunogenicity of the Recombinant (E.Coli) Human Papillomavirus Type 6/11 Bivalent Vaccine in Healthy Volunteers Aged 18-55 Years

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02710851
• Other study ID #: HPV-PRO-005
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 24, 2016
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 640
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Participants 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. Non-pregnancy 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.

Related Conditions & MeSH terms

• Condylomata Acuminata

Intervention

Biological:
• low dosage HPV Vaccine(1:1)
Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
• low dosage HPV Vaccine(1:2)
Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
• high dosage HPV Vaccine(1:1)
Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.
• Hepatitis E vaccine,Hecolin®
Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Jun Zhang	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen Innovax Biotech Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HPV 6 and anti-HPV 11 seroconversion rates (type specific IgG antibody)		7 months
Primary	Anti-HPV 6 and anti-HPV 11 geometric mean concentrations (type specific IgG antibody)		7 months
Secondary	Number of serious adverse events throughout the study	All the serious adverse events throughout the study would be recorded.	7 months