A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age
Overview
- Phase
- Phase 2
- Intervention
- CIC Vaccine with Matrix-M Adjuvant
- Conditions
- COVID-19
- Sponsor
- Novavax
- Enrollment
- 1579
- Locations
- 35
- Primary Endpoint
- Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.
Detailed Description
The study will enroll approximately 2300 (1520 in Part 1 and 800 in Part 2) healthy (based on history and physical examination) adult male and female participants 50 to 80 years of age, inclusive, targeting participants, who must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters\[s\]) ≥ 3 months prior to enrollment. Randomization will be stratified by age ≥ 50 to \< 65 or ≥ 65 to ≤ 80 years to distribute the proportions of each age stratum evenly across vaccine groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be included in this study, each individual must satisfy all the following criteria:
- •Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening.
- •Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
- •Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
- •Absence of medical events qualifying as SAEs within 3 months; and
- •Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
- •The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
- •Willing and able to give informed consent prior to study enrollment.
- •Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
- •Participants must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID 19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters\[s\]) ≥ 8 weeks prior to enrollment (first study vaccination).
Exclusion Criteria
- •If an individual meets any of the following criteria, he or she is ineligible for this study:
- •History of laboratory-confirmed (by Polymerase Chain Reaction (PCR) or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection ≤ 8 weeks prior to enrollment.
- •(NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection \> 8 weeks prior to enrollment is NOT exclusionary)
- •Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
- •Serious chronic diseases inclusive of:
- •Uncontrolled hypertension (NOTE: well controlled hypertension ≤ grade 2 in NOT exclusionary);
- •Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE:
- •mild well-controlled congestive heart failure is NOT exclusionary);
- •Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled COPD is NOT exclusionary);
- •In the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting \[CABG\]) surgery, new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
Arms & Interventions
Group A (Part 1)
CIC Vaccine Formulation1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group B (Part 1)
CIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group C (Part 1)
CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group D (Part 1)
CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group E (Part 1)
CIC Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group F (Part 1)
CIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group G (Part 1)
CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group H (Part 1)
CIC Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group I (Part 1)
CIC Vaccine Formulation 5. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group J (Part 1)
CIC Vaccine Formulation 6. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group K (Part 1)
CIC Vaccine Formulation 7. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group L (Part 1)
qNIV Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: qNIV Vaccine with Matrix-M Adjuvant
Group M (Part 1)
qNIV Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: qNIV Vaccine with Matrix-M Adjuvant
Group N (Part 1)
qNIV Vaccine Formulation 3 . 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: qNIV Vaccine with Matrix-M Adjuvant
Group O (Part 1)
SARS-CoV-2 rS Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group P (Part 1)
SARS-CoV-2 rS Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group Q (Part 1)
SARS-CoV-2 rS Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group R (Part 1)
SARS-CoV-2 rS Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70
Intervention: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant
Group S (Part 1)
Influenza Vaccine Formulation 1. 1 intramuscular (IM) doses of vaccine, on Day 0.
Intervention: Influenza Vaccine
Group T (Part 2)
CIC Vaccine Formulation 8. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable).
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group U (Part 2)
CIC Vaccine Formulation 9. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable).
Intervention: CIC Vaccine with Matrix-M Adjuvant
Group S (Part 1)-Placebo
1 intramuscular (IM) doses of placebo, on Day 70.
Intervention: Placebo Comparator
Outcomes
Primary Outcomes
Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs)
Time Frame: Day 0 to Day 7
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Part 1 and Part 2 : Percentage of participants with all AEs
Time Frame: Day 0 to Day 21
Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.
Part 1 and Part 2 : Percentage of participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Time Frame: Day 0 to Day 182
Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination
Secondary Outcomes
- Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroprotection Rate (SPR)(Day 0 to Day 84)
- Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer Ratio (GMTR)(Day 0 to Day 84)
- Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as SCR(Day 0 to Day 84)
- Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroconversion Rate (SCR)(Day 0 to Day 84)
- Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTs(Day 0 to Day 84)
- Part 1 and Part 2: Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMTR(Day 0 to Day 84)
- Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMTR(Day 0 to Day 84)
- Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Fold Rise (GMFR)(Day 0 to Day 84)
- Part 1 and Part 2: Serum Immunoglobulin G (IgG) to the SARS-CoV-2 spike protein expressed as GMEU(Day 0 to Day 84)
- Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as GMFR(Day 0 to Day 84)
- Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as SCR(Day 0 to Day 84)
- Part 1 and Part 2: Serum IgG to the SARS-CoV-2 spike protein expressed as Geometric Mean ELISA Unit Ratio (GMEUR)(Day 0 to Day 84)
- Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer (GMT)(Day 0 to Day 84)
- Part 1 and Part 2 : Neutralizing Antibody Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and/or Antigenically Drifted Influenza Strains Expressed as GMFR(Day 0 to Day 84)
- Part 1 and Part 2: Microneutralization assay (MN) 50 GMTs to the SARS-CoV-2 expressed as GMTs(Day 0 to Day 84)
- Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as SCR(Day 0 to Day 84)
- Part 1 and Part 2: MN50 GMTs to the SARS-CoV-2 expressed as GMFR(Day 0 to Day 84)