A clinical study to assess the safety and immunogenicity of a quadrivalent Human Papillomavirus vaccine in subjects aged 9 to 26 years of age.

Phase 2/3

Completed

• Conditions: Encounter for immunization,

• Registration Number: CTRI/2018/06/014601
• Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary

Thisis a Phase II/III partially double-blind, randomized, active-controlled,multicentric study with a two-dose schedule (0 and 6 months) to Cohort 1 (Aged9-14 years) and a three-dose schedule (0, 2 and 6 months) to Cohort 2 (Aged15-26 years) having three treatment arms in each cohort.  A total of 600 subjects will be enrolled suchthat 200 girls/women will be enrolled in a randomized and blinded manner in 1:1ratio to either SIIPL’s qHPV vaccine or Gardasil (100 per age cohort) and 100boys/men will be enrolled in a non-randomized and unblinded manner into eachage cohort to receive SIIPL’s qHPV vaccine. Analysis of the reactogenicity andsafety data of all 600 subjects will be performed at 7 months. Further, additionalsubjects will be enrolled in the phase III part of the study. Thus total samplesize would be approx. 2500.  All the enrolledsubjects will be considered for primary immunogenicity analysis (non-inferiority)and safety at 7 month (1 month after last dose).  Additionally, long term follow up data will obtainedtill 36 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Study Completion: 2024-04-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2196

Inclusion Criteria

• 1. Healthy ambulant male and female subjects aged 9-26 years.
• 2. Females with intact uterus and not pregnant.
• Subject who are married/sexually active must agree to use effective contraception through Month 7 of the study.
• 3. Subjects who have not yet had sexual intercourse must either agree to remain abstinent through the 7 month study period, or if they become sexually active during the vaccination phase of the study, to use effective contraception for the 7 month study period.
• 4. Subject’s willingness and ability to comply with the requirements of the protocol as judged by the investigator.
• 5. Subject willing to sign a written informed consent (for subjects 18 years and above).
• 6. Either of the parent is willing to sign written informed consent form and subject is willing to sign written assent form (for subject <18 years of age).
• 7. Married females must agree to refrain from sexual activity for 48 hours prior to any scheduled visit that includes a cervical sample.

Exclusion Criteria

• 1)Subject has a known history of prior vaccination with HPV vaccine.
• 2)Subject concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
• 3. Subject with a current diagnosis or prior history of genital warts or treatment of genital warts.
• 4)Female subject with current diagnosis or history of treatment for cervical pre-malignancies or malignancy.
• 5)Female subject attempting to be pregnant for the study period 7 month.
• 6)Married female subject has clinical evidence of gross purulent cervicitis 7)Male subject with a current diagnosis or prior history of penile or anal cancers.
• 8)Subject has a history of any allergic diseases or severe allergic reaction to any agent 9)Subject has had an acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination.
• 10)Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired Human Immunodeficiency Virus infection.
• 11. coagulation disorder that would contraindicate IM injections.
• 12)Subject has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
• 13)Subject has history of any cancer, organ transplant or any other immune system disease.
• 14)Subject has had chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
• 15)Subject has received any oral or injectable antibiotics and/or antiviral from five days before screening through to enrolment.
• 16)Subject has history of receiving a blood transfusion or other blood products in three months prior to screening.
• 17)Subject has history of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned during the course of 7 month study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GMT of antibodies to 4 HPV types	at 7 months
1.among girls aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil	at 7 months
2.among boys aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil	at 7 months
3.among women aged 15-26 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil	at 7 months
4.among men aged 15-26 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil.	at 7 months
Occurrence, intensity and relationship adverse events of SIIPL qHPV with Gardasil	at 7 months

Secondary Outcome Measures

Name	Time	Method
GMT of 4 HPV types 1.In girls aged 9-14 yrs receiving SIIPL qHPV and Gardasil 2.In boys aged 9-14 yrs receiving SIIPL qHPV and 9-14 yrs of girls of Gardasil 3.At 24,36 month - among girls and boys aged 9-14 yrs receiving SIIPL qHPV and women aged 15-26 yrs receiving Gardasil 4.At 24,36 month - among women and men aged 15-26 yrs receiving qHPV and women aged 15-26 yrs receiving Gardasil	Persistent infections at 12, 24, 36 month in females 15-26 yr

Trial Locations

Locations (13)

All India Institute of Medical Sciences, New Delhi; 🇮🇳 South, DELHI, India

Bharati Vidyapeeth Deemed University Medical College And Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

G. Kappuswami Naidu Memorial Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Grant Medical Foundation Ruby Hall Clinic, Urban Health Centre; 🇮🇳 Pune, MAHARASHTRA, India

Kasturba Medical College; 🇮🇳 Udupi, KARNATAKA, India

King Edward Memorial Hospital Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

M. S. Ramaiah Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Mahatma Gandhi Institute of Medical Sciences; 🇮🇳 Wardha, MAHARASHTRA, India

Scroll for more (3 remaining)

All India Institute of Medical Sciences, New Delhi

🇮🇳South, DELHI, India

Dr Neerja Bhatla

Principal investigator

011-26594991

neerja.bhatla07@gmail.com