Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination

Inclusion Criteria

• Must be aged 18-49 years old (inclusive) at the time of vaccination.
• Must be able to provide written informed consent.
• Must have a body mass index (BMI) >/= 18.5 and /= 1 year of spontaneous amenorrhea), or permanently surgically sterilized (bilateral oophorectomy, salpingectomy, hysterectomy).

**Acceptable methods of contraception include: abstinence or no sex with a male, monogamous relationship with a man who had a vasectomy at least 6 months before the 1st study vaccine, prescription oral contraceptives, intrauterine device (IUD), birth control implants or injections, contraceptive patch, vaginal ring, condoms and diaphragms/cervical cap with spermicide ("double barrier" method).

• Must be available and willing to participate for the duration of this trial.
• Willing to provide mucosal samples: vaginal secretions for women and oropharyngeal and rectal secretions for men and women.
• For the rectal biopsy cohort only, willing to provide rectal biopsies.

Exclusion Criteria

• Has ever been diagnosed with meningococcal infection or gonococcal infection at any anatomic site.
• Has ever received any serogroup B meningococcal vaccine.
• Any positive test result for STI (including Neisseria gonorrhoeae (GC) Chlamydia trachomatis (CT), Rapid Plasma Reagin (RPR) and Human Immunodeficiency Virus (HIV)) at screening*.

*Female subjects will also be tested for Trichomonas at screening.

• Any history of Chlamydia trachomatis or syphilis infection at any body site in the preceding 12 months
• Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products.
• Has severe allergy or anaphylaxis to latex.
• Has an acute illness or temperature >/= 38.0 degrees Celsius on Day 1*.

*Subjects with fever or acute illness on the day of vaccination may be re-assessed and enrolled if healthy or only minor residual symptoms remain within 3 days.

• Has a history of a bleeding disorder, or is taking chronic anti-coagulant (e.g. warfarin, direct thrombin inhibitors, heparin products, etc.), anti-platelet, or non-steroidal anti-inflammatory drugs (NSAID) therapy.
• Has history of autoimmune disease, or clinically significant cardiac, pulmonary, gastrointestinal, hepatic, rheumatologic, or renal disease by history or physical examination.
• Has history of active malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure*.

*Subjects with a history of skin cancer must not be vaccinated at the previous tumor site.

• Has known or suspected congenital or acquired immunodeficiency, or recent history or current use of immunosuppressive therapy*.

*Anti-cancer chemotherapy or radiation therapy within the preceding 3 years, or long-term (>/= 2 weeks within the previous 3 months) systemic corticosteroid therapy (at a dosage of >/= 0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) are allowed.

• Is post-organ and/or stem cell transplant, whether or not on chronic immunosuppressive therapy.
• Had major surgery (per the investigator's judgment) within 4 weeks before study entry or planned major surgery during this trial.
• Has history of diabetes* mellitus type 1 or type 2, including cases controlled with diet alone*.

*History of isolated gestational diabetes is not an exclusion criterion.

• Received live attenuated vaccines from 30 days before first vaccination until 30 days after second vaccination.
• Received killed or inactivated vaccines* from 14 days before first vaccination until 14 days after second vaccination.

*For inactivated influenza vaccine, from 7 days before either vaccination until 7 days after either vaccination.

• Received mRNA, viral vector, or any other technology platform Corona Virus Disease-19 (COVID-19) vaccine within 14 days prior to first dose of the study product.*

*COVID-19 vaccination should take priority over administration of t