Clinical trial to demonstrate the immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in healthy adults

Phase 3

Completed

• Conditions: Prevention of pneumococcal disease

• Registration Number: CTRI/2021/09/036860
• Lead Sponsor: GCChemie Pharmie Ltd

Brief Summary

Pneumococcal infection is a leading cause of death throughout the world and a major cause of pneumonia, bacteremia, meningitis, and otitis media. It has been established that purified pneumococcal capsular polysaccharides induce antibody production and such antibody is effective in preventing pneumococcal disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular serotypes when tested in polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children aged two years and above as well as adults of all ages have showed immunogenic response. In order to provide more evidence for the immunogenicity and the safety of the vaccine on Indian population, a phase III clinical trial is planned for for 23-Valent Pneumococcal Polysaccharide Vaccine manufactured by Yuxi Walvax Biotechnology Co., Ltd

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-10
• Study Completion: 2022-02-03
• Last Update Posted: 2022-06-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Subjects aged between 18 to 65 years; Subjects willing to give written informed consent prior to the study entry; Subjects with good health as determined by: Medical history; Physical examination; Clinical judgment of the investigator.
• Subjects able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria

• Subjects administered with any pneumococcal vaccine before vaccination; Subjects with history of pneumococcal infection; Women in pregnancy or lactation period in trial period; Subjects with allergic history or any SAE after vaccination,such as allergy, urticaria, dyspnoea, angioedema Subjects with known or suspected immune dysfunction, including persons with congenital immunodeficiency or persons with HIV positive; Subjects with functional or anatomic asplenia; Patients treated with chemotherapy in past 5 years or administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in 6 months preceding the vaccine trial; Subjects with receipt of blood or blood-derived products in 3 months preceding vaccination; Subjects participating in another clinical study investigating a vaccine or drug in 30 days preceding vaccination; Subjects with receipt of any live virus vaccine in 30 days preceding vaccination; Subjects with receipt of any subunit vaccine and inactivated vaccine in the 14 days before vaccination; Subjects with thrombocytopenia or bleeding disorder; Subjects with history of asthma, angioneurotic edema, diabetes mellitus or malignancy tumour; Subjects with history of thyroid gland excision or treatment for thyroid gland disease in last 12 months.
• Subjects with hypertension or whose blood pressure is still above 145/95mmHg even with drug treatment; Subjects with history of eclampsia, epilepsia or psychosis; Subjects with febrile illness (temperature ≥ 38°C) in 3 days or any acute illness/infection in 7 days preceding vaccination; Subjects with anti-tuberculosis prophylaxis or therapy in progress; Those who cannot fulfil the protocol or cannot sign the informed consent form for any medical, psychological, social, occupational and other reasons, according to investigator judgment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects exhibiting a ≥ 2-fold increase in antipneumococcal IgG antibody level for all included 23 serotypes after vaccination in each group.	Antibody response at Day 28 post-vaccination
Geometric mean fold increase (GMFI) and geometric mean concentration/titer (GMCs/GMTs) of IgG after vaccination in each group.	Antibody response at Day 28 post-vaccination

Secondary Outcome Measures

Name	Time	Method
Incidence of unsolicited adverse events	Day 28 post-vaccination
Incidence of systemic and local adverse reactions in healthy subjects after vaccination (up to 30 minutes) and in 7	subsequent days
Incidence of SAE during the entire study period	During the entire study period

Trial Locations

Locations (6)

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

All India Institute of Medical Sciences Patna; 🇮🇳 Patna, BIHAR, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Niloufer Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Prakhar Hospital; 🇮🇳 Nagar, UTTAR PRADESH, India

Rana Hospital; 🇮🇳 Gorakhpur, UTTAR PRADESH, India

Aatman Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Chintan B Patel

Principal investigator

9825182251

cr.aatman@gmail.com