Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children

Официальное название

A Phase 2, Open-Label, Single-Center, Long-Term Immunogenicity Follow-Up Study of the GVGH altSonflex1-2-3 Shigella Vaccine 1, 2 and 3 Years After Vaccination in African Children

Обзор

The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06\_01TP study \[NCT05073003, 212149\]) and a study with an alternate 2 vaccination schedule H06\_02TP study \[NCT06663436, 219449\]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.

Вмешательства

• Биопрепарат AltSonflex1-2-3
  No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06\_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06\_02TP (219449) study.
• Биопрепарат Menveo
  No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06\_01TP (212149) parent study.
• Биопрепарат Infanrix hexa
  No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06\_01TP (212149) study; or on Day 169 during the H06\_02TP (219449) parent study.
• Биопрепарат TYPHIBEV
  No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06\_02TP (219449) parent study.

Первичные конечные точки

• Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA) [Срок оценки: At Visit 1 of the current study (12 months after last vaccination in the parent studies)]
• Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA [Срок оценки: At Visit 2 of the current study (24 months after last vaccination in the parent studies)]
• Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA [Срок оценки: At Visit 3 of the current study (36 months after last vaccination in the parent studies)]

Критерии участия

Критерии включения

• Children who, as infants, previously participated in two completed studies (H06\_01TP or H06\_02TP) and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-3 vaccination.
• Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.

Критерии исключения

• Serious and significant progressive, unstable, or uncontrolled clinical condition(s).
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Clinical condition(s) representing a contraindication to blood draws.
• Any behavioural or cognitive impairment or psychiatric disease.
• Acute disease and/or fever at the time of enrollment.
• Individuals with known or suspected HIV infection or HIV-related disease, with history of an autoimmune disorder or any other known or suspected impairment/alteration of the immune system, or under immunosuppressive therapy.
• Receipt of immunoglobulins and/or any blood products or plasma derivatives, during the period starting 3 months before each study visit.

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

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07320716 · 223136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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