Table 2.
Summary of clinical trials of CYD vaccine.
| Study code [ref] | Phase | Purpose | Formulation; Schedule | Age Range (years except where months are noted) | Country |
|---|---|---|---|---|---|
| CYD0152 | 1 | Safety, vaccine viremia, immunogenicity, effect of priming by yellow fever vaccine | Monovalent ChimeriVax™- DEN2 at 3 or 5 log10 PFU; single dose |
18–49 | USA |
| CYD02[FDA briefing document, https://www.fda.gov/media/120943/download)] | 1 | Safety, vaccine viremia, immunogenicity in dengue non-endemic area | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/3.5/12 months | 18–45 | USA |
| CYD0453 | 1 | Safety, vaccine viremia, immunogenicity in dengue non-endemic area | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/3.5/12 months | 18–45 | USA |
| CYD0554 | 1 | Safety, vaccine viremia, immunogenicity in dengue endemic area including children, antibody persistence | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/3.5/12 months | 2–45 | Philippines |
| CYD0655 | 1 | Safety, vaccine viremia, immunogenicity in dengue non-endemic area including children | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/3.5/12 months | 2–45 | Mexico |
| CYD0856 | 2 | Safety, immunogenicity of concomitant Pentaxim™ | 12–15 months | Philippines | |
| CYD1057 | 2 | Safety, vaccine viremia, immunogenicity, effect of priming by classically attenuated live dengue vaccine | Tetravalent CYD 5/5/5/5 log10 CCID50; single dose | 18–40 | Australia |
| CYD1158 | 2 | Safety, vaccine viremia, immunogenicity with bivalent and tetravalent formulations in flavivirus-naive adults and those primed by JE vaccine | Bivalent CYD1/3 & 2/4 at 5/5 log10 CCID50; Tetravalent CYD 5/5/5/5 log10 CCID50; 0/105 days | 18–45 | Mexico |
| CYD1259 | 2 | Formulation comparison | Tetravlent CYD 5/5/5/5 vs 5/5/5/3 vs 4/4/4/4 log10 CCID50; 0/6/12 months | 18–45 | USA |
| CYD1360 | 2 | Safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–16 | Colombia, Honduras, Mexico, Puerto Rico |
| CYD2261,62 | 2 | Safety, immunogenicity, antibody persistence | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 2–45 | Vietnam |
| CYD2463 | 2 | Safety, vaccine viremia, immunogenicity in Yellow fever | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 2–11 | Peru |
| CYD2862,64,65 | 2 | Safety, immunogenicity, persistence of immune response | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 2–45 | Singapore |
| CYD3066 | 2 | Safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–16 | Brazil |
| CYD4767 | 2 | Safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 18–45 | India |
| CYD5168 | 2 | Immunogenicity in Yellow fever vaccinated subjects | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 18–45 | USA |
| CYD56 [ClinicalTrialss.gov NCT01943825] | 2 | Immunogenicity with compressed schedule and JE vaccine co-administration | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/2/6 months & 0/6/12 months | 18–45 | USA |
| CYD63 [ClinicalTrials.gov NCT02824198] | 2 | Safety, immunogenicity of booster dose in subjects from CYD28 | Tetravalent CYD 5/5/5/5 log10 CCID50; single booster dose | 2–45 (at enrollment in CYD28) | Singapore |
| CYD6469 | 2 | Safety, immunogenicity of booster dose in subjects from CYD13 and CYD30 | Tetravalent CYD 5/5/5/5 log10 CCID50; single booster dose | 9–16 (at enrollment in CYD13 or CYD30) | Brazil, Colombia, Honduras, Mexico, Puerto Rico |
| CYD65 [ClinicalTrials.gov NCT02628444] | 2 | Immunogenicity of 1 vs 2 vs 3 dose primary series and booster | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months (with 0, 1 or 2 placebos) followed by single booster dose 1–2 years after 3rd injection | 9–50 | Colombia, Philippines |
| CYD2349,70,71 | 2b | Proof-of-concept efficacy, safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 4–11 | Thailand |
| CYD5770-72 | 2b | Long-term safety follow-up of CYD23 subjects | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 4–11 at enrollment in CYD23 | Thailand |
| CYD1773 | 3 | Lot consistency | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 18–60 | Australia |
| CYD2974,75 | 3 | Safety, immunogenicity of concomitant Yellow fever vaccine | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 12–13 -months | Colombia, Peru |
| CYD3276 | 3 | Safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 2–11 | Malaysia |
| CYD3377 | 3 | Safety, immunogenicity of concomitant Pentaxim™ | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–12 months | Mexico |
| CYD66 [ClinicalTrials.gov NCT02992418] | 3 | Safety, immunogenicity of concomitant tetanus/diphtheria/pertussis vaccine | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–60 | Philippines |
| CYD67 [ClinicalTrials.gov NCT02993757] | 3 | Safety, immunogenicity of concomitant human papilloma virus vaccine | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–13 | Malaysia |
| CYD71 [ClinicalTrials.gov NCT02979535] | 3 | Safety, immunogenicity of concomitant human papilloma virus vaccine | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–14 | Mexico |
| CYD1450,70-72 | 3 (efficacy) | Pivotal efficacy, safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 2–11 | Indonesia, Malaysia, Thailand, Philippines, Vietnam |
| CYD1551,70-72 | 3 (efficacy) | Pivotal efficacy, safety, immunogenicity | Tetravalent CYD 5/5/5/5 log10 CCID50; 0/6/12 months | 9–16 | Brazil, Colombia, Honduras, Mexico, Puerto Rico |