Table 2.

Characteristics of AVTs, antibiotics and vaccines *.

Characteristics	AVTs	Antibiotics	Hypothetical Vaccine
Mode of action	Selective inhibition of pathogens, preserves the microbiome	Broad spectrum killing of microorganisms, removes the microbiome	Selective inhibition of pathogen, preserves the microbiome
Mechanism of action	Tailored to prevent colonization, transmission, and infection by a pathogen	Kills systemic microorganisms—resolves acute infections. Not used for asymptomatic infections	Prevents acute infection by a pathogen. In some instances, vaccines can prevent colonization and transmission of the pathogen.
Use	Pre-exposure prophylaxis or therapeutic	Therapeutic	Pre-exposure therapeutic
Dose	Multiple dosing as needed	Multiple dosing, 3–4 days	1–3 doses
Route of administration	Oral, topical	Oral, injectable	Injectable
Correlate of protection	Absence of viable pathogen at the site of infection	Absence of viable pathogen at the site of infection	Currently unknown
Implementation	Pharmacy or medical prescription	Medical prescription	Primary care clinics
Size and cost of clinical trials	>1000 subjects ** <$1 billion	>10,000 subjects >$1.5 billion	>100,000 subjects >$1.8 billion
Drug development timeframe from pre-clinical to licensing	5–10 years **	9–15 years	9–15 years
Licensing pipeline

* Information tabulated from Paul et al. (2010) [294] and Farha and Brown (2019) [291]. ** Provisional estimates as the licensing pipeline has not been fully established for AVTs against N. gonorrhoeae. LO: Lead optimization. P 0: Phase 0. P I/II/III: Phase I/II/III. IND: investigational new drug application. NDA: new drug application. FDA: United States Food and Drug Administration (FDA) review and approval.