2026-526939-19-00招募中2 期
Phase 1/2, first-in-human, randomized, double-blind, reference-controlled study to evaluate the safety and immunogenicity of an extemporaneously mixed Combo Inactivated Influenza Vaccine (Green Cross [GC]-IIV; 15µg of each hemagglutinin [HA])/OVX836 (480µg), in comparison to GC-IIV (15µg of each HA) concomitantly administered with OVX836 (480µg), GC-IIV alone (15 µg each HA), OVX836 alone (480µg), and a licensed reference trivalent IIV (Vaxigrip®; 15µg of each HA), administered intramuscularly (IM) in healthy participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Osivax
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Occurrence of SAEs during the whole study duration in each group.
研究概览
简要总结
To assess the safety and reactogenicity of the extemporaneously mixed Combo vaccine containing GC-IIV (15µg of each HA) and OVX836 (480µg) administered IM.
研究设计
- 分配方式
- Randomized
- 主要目的
- Study Phase 2
- 盲法
- Double (Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy male or female participants, as determined by medical history and medical examination. Refer to Appendix A for reproductive criteria for male and female participants
- •Participants aged 18 to 49 years, inclusive
- •Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
- •Ability and technical possibility for completing an eDiary.
排除标准
- •Participants with a body mass index (BMI) ≤19 kg/m² or ≥35 kg/m² on the day of vaccination.
- •Participant with hyperhydration, hypernatremia, or hyperchloremia.
- •Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines.
- •Planning to receive other vaccines during the first 28 days following the study vaccine administration.
- •Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
- •Current participation in another clinical study at screening or anticipated participation in another clinical trial during the course of this study.
- •History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.
- •Blood donation ≥450 mL within one month before screening or during study participation.
- •Presence of an acute illness or febrile episode on the day of vaccination (oral temperature >38.0°C, temporary exclusion criterion).
- •Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- •Behavioral or cognitive impairment, or psychiatric disease (depression, mania, bipolar disorder, schizophrenia) that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
- •Previously exposed to OVX836 vaccine, whatever the dose.
- •Past (stopped less than 6 months before enrolment) or current history of alcohol abuse, or current smoking habit above 10 cigarettes per day, or current vaping.
- •Participants with a history of recreational drug use or current use of illicit substances.
- •Participants with current or unstable respiratory conditions, including but not limited to asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, pulmonary hypertension, cystic fibrosis, or acute respiratory infections.
- •Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.
- •History of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study vaccines, in particular egg proteins and/or kanamycin
- •Any contraindication to IM administration, as judged by the Investigator.
- •Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the participants due to participation in the study.
- •Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
- •Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the study duration.
- •Pregnant or lactating woman.
- •Any known or suspected immunodeficient conditions.
- •Past or current history of autoimmune diseases, as judged by the Investigator.
- •Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
- •Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- •Abnormal safety laboratory parameter(s)
研究组 & 干预措施
Vaxigrip suspension injectable en seringue préremplie Vaccin grippal trivalent (virion fragmenté, inactivé)
Comparator
干预措施: Vaxigrip suspension injectable en seringue préremplie Vaccin grippal trivalent (virion fragmenté, inactivé) (Drug)
OVX836C2
Test
干预措施: OVX836C2 (Drug)
Sodium Chloride Intravenous Infusion BP 0.9% w/v Solution for Infusion
Placebo
干预措施: Sodium Chloride Intravenous Infusion BP 0.9% w/v Solution for Infusion (Drug)
OVX836
Comparator
干预措施: OVX836 (Drug)
GC FLU
Comparator
干预措施: GC FLU (Drug)
结局指标
主要结局
Occurrence of SAEs during the whole study duration in each group.
Occurrence of SAEs during the whole study duration in each group.
Occurrence of AESI and/or NOCDs during the whole study duration in each group.
Occurrence of AESI and/or NOCDs during the whole study duration in each group.
Number and percentage of participants reporting unsolicited AEs during 28 days after vaccine administration in each group.
Number and percentage of participants reporting unsolicited AEs during 28 days after vaccine administration in each group.
Number and percentage of participants reporting solicited local and systemic signs and symptoms during seven days after vaccine administration in each group.
Number and percentage of participants reporting solicited local and systemic signs and symptoms during seven days after vaccine administration in each group.
Number and percentage of participants with deviations from normal values (judged clinically relevant or not by the Principal Investigator [or Co-Investigators]) of safety laboratory tests during 28 days after vaccine administration, in each group.
Number and percentage of participants with deviations from normal values (judged clinically relevant or not by the Principal Investigator [or Co-Investigators]) of safety laboratory tests during 28 days after vaccine administration, in each group.
次要结局
- HAI geometric mean titers (GMTs) on Day 1 (pre-injection baseline), Day 29 and Day 180 for each of the three strains contained in the seasonal vaccines, in each group.
- Assessment of the CHMP and FDA requirements for seasonal influenza vaccines in each group: Seroconversion rate at Day 29 and Day 180 versus preinjection baseline (Day 1) determined using HAI, for the three influenza strains contained in the GC-IIV and reference licensed IIV (Vaxigrip®).
- Assessment of the CHMP and FDA requirements for seasonal influenza vaccines in each group: Proportion of participants achieving a titer ≥1:40 at Day 29 and Day 180 determined using HAI, for the three influenza strains contained in the GC-IIV and reference licensed IIV (Vaxigrip®).
- Assessment of the CHMP and FDA requirements for seasonal influenza vaccines in each group: HAI titers Day 29/Day 1 and Day 180/Day 1 geometric mean ratios (GMRs) for the three influenza strains contained in the GC-IIV and reference licensed IIV (Vaxigrip®).
- Cell-mediated immune response in terms of change of NPspecific spot-forming unit number in PBMCs upon relevant in vitro stimulation, measured by IFNγ ELISPOT, at Day 8 and Day 29, versus pre-injection baseline (Day 1) in each group.
- NP-specific CD4+ and CD8+T-cell percentages measured by flow cytometry (on PBMCs), identified as expressing markers such as IL-2, TNFα and/or IFNγ, upon relevant in vitro stimulation at Day 1 (pre-injection baseline), Day 8 and Day 29, in each group.
- GMTs of anti-NP immunoglobulin G (IgG) (ELISA, serum) at Day 1, Day 29 and Day 180 in each group.
- Number and percentage of participants with an increase (fourfold) in anti-NP IgG (ELISA, serum) titer on Day 29 and Day 180, with respect to pre-injection baseline (Day 1), in each group.
- GMTs of anti-OVX313 tag (Oligodom®) IgG level (ELISA, serum) at Day 29 and Day 180 versus pre-injection baseline (Day 1) in each group.
- Number and percentage of participants reporting ILI episodes and RT-PCR-confirmed influenza Type A or influenza Type B diseases
研究者
研究点 (1)
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