Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age

Официальное название

A Phase 1, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Healthy Participants 18 to 49 Years of Age

Обзор

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years. The total duration of study participation for each participant varies by stage and treatment arm. Stage 1: * For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant. * For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant. Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.

Вмешательства

• Биопрепарат H5 Flu Investigational Medical Product (IMP) 1
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат H5 Flu IMP 2
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат H5 Flu IMP 3
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат RSV IMP 4
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат RSV IMP 5
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат RSV IMP 6
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат H5 Flu IMP 7
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат H5 Flu IMP 8
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат H5 Flu IMP 9
  Suspension for injection. Route of administration: Intramuscular (IM) injection
• Биопрепарат H5 Flu IMP 10
  Suspension for injection. Route of administration: Intramuscular (IM) injection

Первичные конечные точки

• Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination [Срок оценки: On Day 1]
• Presence of solicited injection site reactions (ie, injection site pain, injection site erythema, injection site swelling, pre-listed in participant's diary and in the eCRF (electronic case report form)) occurring through 7 days after each vaccination [Срок оценки: Day 1 through day 8]
• Presence of solicited systemic reactions (ie, fever, headache, and only new or worsened fatigue, myalgia, arthralgia, and chills pre-listed in the participant's diary and in the eCRF) occurring through 7 days after each vaccination [Срок оценки: Day 1 through day 8]
• Presence of unsolicited AEs reported through 20 days after the first vaccination and after the second vaccination for IMPs with the Flu H5 antigen [Срок оценки: Day 1 through day 21]
• Presence of unsolicited AEs reported through 28 days after vaccination for IMPs with the RSV antigen [Срок оценки: Day 1 through day 29]
• Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination) [Срок оценки: SAE: Screening day through day 202 (IMPs containing Flu H5 antigen), Screening day through day 181 (IMPs containing RSV antigen); AESI: Day 1 through day 202 (IMPs containing Flu H5 antigen), Day 1 through day 181 (IMPs containing RSV antigen)]
• Presence of out-of-range biological test results (including shift from baseline values) through 7 days after each vaccination [Срок оценки: Screening through day 8]
• Presence of AEs leading to study discontinuation throughout the study (ie, through 6 months after vaccination) [Срок оценки: Screening through day 202 (IMPs containing Flu H5 antigen), Screening through day 181 (IMPs containing RSV antigen)]
• RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants receiving IMPs with the RSV antigen [Срок оценки: Day 1 and day 29]
• Flu H5 antibody (Ab) titer measured by hemagglutination inhibition (HAI) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen [Срок оценки: Day 1, day 22 and day 43]

Вторичные конечные точки (5)

• Geometric mean neutralizing antibody titers measured by Neutralization Assay (NT) at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen [Срок оценки: Day 1, day 22, and day 43]
• Neutralizing antibody titer ratio at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen [Срок оценки: Day 1, day 22, and day 43]
• Proportion of participants with neutralizing antibody titers ≥20, ≥40, and ≥80 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen [Срок оценки: Day 1, day 22, and day 43]
• Proportion of participants with detectable neutralizing antibody titers ≥10 at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen [Срок оценки: Day 1, day 22, and day 43]
• Proportion of participants with ≥2-fold and ≥4-fold increase in neutralizing antibody titers at pre-vaccination and 21 and 42 days post-vaccination in all participants receiving IMPs with the Flu H5 antigen [Срок оценки: Day 1, day 22, and day 43]

Критерии участия

Критерии включения

• Aged 18 to 49 years on the day of inclusion
• A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
• Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
• Is of CBP (Child-Bearing Potential) and uses an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after the last study intervention administration.

Критерии исключения

• Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Австралия · 6 центров

• Site # 0361002 — Griffith
• Site # 0361001 — Herston
• Site # 0361003 — Morayfield
• Site # 0361005 — Sippy Downs
• Site # 03610004 — South Brisbane
• Site # 036006 — Taringa

Идентификаторы

NCT: NCT07516418 · VAV00053 · U1111-1322-6386

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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