Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults

Официальное название

A Phase 1, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults

Обзор

The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).

Подробное описание

This study is a double-blinded, randomised, active controlled, Phase 1 clinical study, to determine the safety, tolerability, and reactogenicity of Serum Institute of India Pvt Ltd (SIIPL) rPV vaccine in comparison to the commercially available inactivated poliovirus vaccine (IPOL®, Sanofi) in up to 36 healthy adults aged between 18 and 60 years. This study will be conducted at a single study site in Australia.

Participants will be randomised in a 2:1 ratio, to receive either investigational vaccine (rPV) or comparator vaccine (IPOL), respectively. The study vaccine will be administered as a single intramuscular (IM) injection into the deltoid muscle of the non-dominant upper arm. The participants will be followed for 30 days post vaccination.

Вмешательства

• Биопрепарат Recombinant Poliomyelitis Vaccine (rPV)
  Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
• Биопрепарат Inactivated Poliomyelitis Vaccine (IPOL)
  IPOL (inactivated poliovirus vaccine) is a marketed Sanofi

Первичные конечные точки

• The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination [Срок оценки: 30 days]

Вторичные конечные точки (1)

• Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30. [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Healthy Volunteers aged between 18 to 60 years inclusive.
• Good physical and mental health based on medical history, physical examination, clinical laboratory,electrocardiogram (ECG), and vital signs, as judged by the Investigator.
• Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8,and Day 30..
• Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit.
• Participants must agree to use highly effective contraception from Day 1 until 90 days after the last studyvisit.

Критерии исключения

• History of Polio
• Any vaccination received 30 days before Screening and Day 30
• Pregnant or lactating females
• BMI >35.0kg/m2
• History of alcohol abuse or drug addiction
• Have received any polio vaccines within 6 months prior to screening.
• History of major surgeries
• History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior tostudy vaccination
• any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Австралия · 1 центр

• Doherty Clinical Trials Limited — East Melbourne

Идентификаторы

NCT: NCT07688369 · SII-rPV-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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