Approximately 330 unvaccinated participants based in the US and its territories and/or Rest of World (ROW) and with a clinical history of COVID-19-like disease during the previous year will receive a booster dose of NVX-CoV2601 on Day 1.
Novavax, Inc. developed a recombinant prototype COVID-19 vaccine constructed from the full-length ancestral (Wuhan) SARS-CoV-2 S glycoprotein (GP) adjuvanted with the saponin based Matrix-M adjuvant (NVX-CoV2373). Subsequently, the SARS-CoV-2 Omicron variant and subvariants emerged with enhanced transmissibility and the most significant number of mutations in any strain to date. Current evidence demonstrates that variant strain mutations such as those in the Omicron XBB.1.5 sublineage confer the ability to evade both natural and vaccine induced neutralizing antibodies. On 26 January 2023, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to harmonize the vaccine strain composition of primary series and booster vaccinations into a single composition for the fall 2023 vaccination campaign.
We are doing part 2 of the study. Part 2 of the study aims to investigate safety and immunogenicity of 1 dose of NVX-CoV2601 in baseline SARS-CoV-2 seropositive COVID-19 vaccine naïve participants to determine if it induces non-inferior antibody responses compared to a booster dose of NVX-CoV2601 in previously COVID-19 mRNA vaccinated individuals participating in Part 1
Criteria:Medically stable male and nonpregnant females ≥ 18 years of age, unvaccinated to SARS-CoV-2 with a clinical history of COVID-19-like infection during the previous year.
To be vaccinated in this study, each individual must satisfy all the following criteria:
1. Adults ≥ 18 years of age at time of study vaccination.
2. Part 2: Participants unvaccinated to SARS-CoV-2 with a clinical history of COVID-19-like disease during the previous year
3. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
4. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study. a. Condoms (male or female) with spermicide (if acceptable in country) b. Diaphragm with spermicide c. Cervical cap with spermicide d. Intrauterine device e. Oral or patch contraceptives f. Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy g. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
5. Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to study vaccination.
6. Agrees not to participate in any research involving receipt of investigational products (drug/biologic/device) including other SARS-CoV-2 prevention or treatment trials for the duration of the study. NOTE: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.