Immunotherapeutic Vaccine

mRNA as a therapy for HIV infection was tested in two clinical trials where it was administered intranodally. Although immunogenicity in the Phase I trial appeared promising [92], the second, a phase 2 trial, was terminated after the interim analysis due to lack of immunogenicity above that seen with the placebo.

## Immunoprophylaxis via Provision of mRNA Encoding a Monoclonal Antibody

One company recently announced in a press release [93] (no citations found on PubMed for the entity) that a clinical trial has been initiated with mRNA encoding a monoclonal antibody for use in prevention of Chikungunya virus infection.


**3.** Clinical trials for mRNA prophylactic vaccines for infectious diseases.

**Table**  **Table 4.** Clinical Phase I and II trials of mRNA excluding prophylactic infectious diseases (see Table 3) and ex vivo-transduced cells. Information is taken from https://clinicaltrials.gov.

RNA-based Adjuvant: long-chain non-coding RNA complexed with a short cationic peptide (ssRNA adjuvant); no mRNA-encoded antigen


Therapeutic mRNA Vaccines for Infectious Disease Targets

	- a. Phase 1, Completed; NCT02413645 [92]
	- b. Phase 2, Terminated due to no immunogenicity above placebo at interim analysis; NCT02888756

mRNA Monoclonal Antibody Prophylaxis for Infectious Disease Targets

• Chikungunya: Monoclonal antibody prophylaxis, Phase 1, Recruiting; NCT03829384

mRNA Vaccines for Cancer (excluding studies where cells are transfected ex vivo, and excluding when no antigen-encoding mRNA is given); multiple groups/companies are sponsors

