• Vaccine Name: (rBCG-N-hRSV) Recombinant Mycobacterium bovis BCG vaccine
• Target Pathogen: Human Respiratory Syncytial Virus
• Target Disease: Respiratory tract disease
• Product Name: rBCG-N-hRSV
• Manufacturer: IDT Biologika
• Type: Recombinant vector vaccine
• Status: Clinical trial
• Location Licensed: Pontifcia Universidad Catholics de Chile
• Host Species for Licensed Use: None
• Antigen: (Abarca et al., 2020) N protein
• Preservative: (Abarca et al., 2020) Antigen T cells
• Preparation: 0.05 mL of a reconstituted vial (2-8*10^6 CFU of the bacteria per 0.1 mL) of this vaccine is administered. This results in 1-4*10^5 CFU to a newborn.
• Immunization Route: Intradermal injection (i.d.)
• Description: (Abarca et al., 2020) rBCG-N-hRSV is a live attenuated recombinant Mycobacterium bovis BCG based on the Danish strain 1331 that expresses the nucleoprotein (N) of RSV (rBCG-N-hRSV)(BCG) that expresses the nuclei protein (N) of RSV.

Human Response

• Host Strain: Danish strain
• Host age: 18-50 years
• Host gender: (Abarca et al., 2020) male
• Vaccination Protocol: In each cohort, participants were vaccinated with 0.1 mL of the vaccine, as follows: 6 volunteers in Cohort A were vaccinated with the lowest dose (5 × 10^3 CFU); 6 volunteers in Cohort B received the middle dose (5 × 10^4 CFU); 6 volunteers in Cohort C received the highest dose (1 × 10^5 CFU) of the study vaccine. Each cohort included two volunteers vaccinated with 0.1 mL of the standard BCG vaccine (BCG-WT; a full dose of 1-33 × 10^5 CFU).
• Vaccination Groups:

  No.	Group Name	Number of Animals	Dose	Route	Gender	Age	Control Group?	Comment	Vaccination Detail
  1	BCG control vaccine		1-33*10^5 CFU in volume 0.1 ml	Intradermal injection (i.d.)	male	18-50 year	yes	Each cohort included 2 volunteers with the standard BCG vaccine as the control group
  2	Cohort A		5*10^3 CFU in volume 0.1 ml	Intradermal injection (i.d.)	male	18-50 year	no
  3	Cohort B		5*10^4 CFU in volume 0.1 ml	Intradermal injection (i.d.)	male	18-50 year	no
  4	Cohort C		1*10^5 CFU in volume 0.1 ml	Intradermal injection (i.d.)	male	18-50 year	no

• Immune Response: (Abarca et al., 2020) Both immunogenicity and reactogenicity responses were lower in BCG-WT immunized volunteers as compared to volunteers immunized with the study vaccine. N-RSV immune responses increased with higher doses of the vaccine
• Side Effects: (Abarca et al., 2020) General (systemic) solicited AEs included fever, tachycardia, hypo/hypertension, headache, fatigue, myalgia, nausea/vomiting, and diarrhea.
• Challenge Protocol: The findings with rBCG-N-hRSV vaccine are consistent with previous studies that showed that it induces a Th-1 RSV-specific immune response in mice, which was protective against RSV challenge
• Efficacy: (Abarca et al., 2020) rBCG-N-hRSV vaccine candidate was safe, well tolerated, and immunogenicity in healthy male adult volunteers. Both immunogenicity and reactogenicity responses were lower in control group as compared to volunteers immunized with the study vaccine. Individuals did not show enhancement of RSV disease.