Clinical Trials of Pandemic Vaccines: Key Issues. John Treanor University of Rochester Rochester, NY
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1 Clinical Trials of Pandemic Vaccines: Key Issues John Treanor University of Rochester Rochester, NY
2 Inactivated vaccine approach Proven technology Used successfully in 1957 and 1968 Abundant efficacy data in both pandemic and interpandemic years Very safe, with large safety database Manufacturing capacity exists in potentially large scale Licensing would be relatively straightforward
3 Inactivated vaccine approach Unlikely to induce mucosal immunity May be less effective in preventing spread Protection may be strain specific Little if any cellular immune response Requires multiple doses Manufacturing capacity limited by availability of eggs and capacity for expansion limited Cell culture strategies might circumvent this problem
4 Recent clinical evaluations of potential pandemic viruses Duck Singapore/97 (H5N3) as a vaccine for Hong Kong/97 Recombinant, baculovirus-expressed HA of A/Hong Kong/156/97 (H5) Whole virion A/Singapore/1/57 (H2N2) and A/Hong Kong/173/99 (H9N2) Whole virion and subunit A/Hong Kong/173 (H9N2)
5 Egg-grown Duck/Singapore No adjuvant MF59 adjuvant ug HA H5N3 Neutralization GMT ug HA 3 ug HA Study day Study day Nicholson et al Lancet 357:1937, 21
6 Egg-grown Duck/Singapore Duck Singapore Hong Kong ug HA 15 ug HA SRH GMT (mm 2 ) SRH GMT (mm 2 ) ug HA Study day Study day Nicholson et al Lancet 357:1937, 21
7 Reimmunization with Duck/Singapore Microneutralization GMT Base Day mo Day 21 MF59 Plain Stephenson et al, Vaccine 21:1687, 23
8 Key issues [1] Development of standardized, validated surrogate markers of protection Responses to inactivated vaccines may be very strain specific evaluation of strategies to broaden responses Adjuvants should be evaluated. Ratio of antigen to adjuvant may be important Pre-pandemic priming dose with heterologous variants should be explored Dose responses relationships may not be obvious
9 Recombinant rha H5 Vaccine Insect cell expressing rha RBCs Purified rha H5 SDS-PAGE
10 Phase I evaluation of rh5 Randomized to interval between doses (21, 28, or 42 days) and then to dose groups (9 ug, 45 ug, 25 ug, 9/1 ug, placebo) - Total of 15 groups Vaccine or placebo administered in total of 1 ml by i.m. injection Sera before and 14 days after dose 1, and before and 7, 14, 21, and 28 days after dose 2
11 ELISA vs. A/HK/156 virus OD value ug 45 ug 9 ug 9 ug / 1 ug Placebo Treanor Vaccine 19:1732, 21 S1 S2 S3 S4 S5 S6 S7
12 Neutralization titers Log2 titer ug 45 ug 9 ug 9 ug / 1 ug Placebo 3.5 S1 S2 S3 S4 S5 S6 S7 Treanor Vaccine 19:1732, 21
13 Response rates Dose 25 ug 45 ug 9 ug 9 ug/ 1 ug Placebo No. of subjects Percent of subjects responding by the following tests after 1 or 2 doses 156 ELISA 483 ELISA Neutralization Dose Dose Dose Dose Dose ELISA: increase of.8 OD units or more 483 ELISA: 2-fold or greater increase in unitage Neutralization: 4-fold or greater increase to a titer of 1:8 or greater, confirmed with positive Western blot Dose
14 Effect of interval 6 21 Days 28 Days 42 Days Log2 Neut Neutralization O D value ELISA 3 S1 S2 S3 S4 S5 S6 S7 S1 S2 S3 S4 S5 S6 S7 Treanor Vaccine 19:1732, 21
15 Critical issues [2] Development of validated high-throughput tests Interval does not seem to be important Shorter intervals result in more rapid effect Effects on duration of antibody are not known Expressed HA proteins are not a validated strategy for influenza control Studies to demonstrate efficacy against conventional influenza
16 Critical issues [3] Is the H5 HA intrinsically less immunogenic? Studies in humans are small and limited Some experiences in animal models with less than expected results Might be assay issue Mechanism unclear
17 Evaluation of whole virus H2N2 vaccine with alum 14 GMT HAI Antibody ug HA (SV) 7.5 ug HA + Al 3.8 ug HA + Al 1.9 ug HA + Al Study Day Hehme et al, Med Microbiol Immunol 191:23, 22; Virus Res 13:163, 24
18 Evaluation of whole virus H9N2 vaccine with alum 14 GMT HAI Antibody ug HA (WV) 7.5 ug HA + Al 3.8 ug HA + Al 1.9 ug HA + Al Study Day Hehme et al, Med Microbiol Immunol 191:23, 22; Virus Res 13:163, 24
19 Geometric mean 5% MN (H9N2) antibody titres to WV and SU vaccines Whole virus Subunit GMT H9 nt titer µg 15µg 3µg day day 21 day day day 21 day 42 Stephenson Lancet 362:1959, 23
20 2 15 Age effect on GMT HI responses WV <35 years of age 2 15 SU <35 years of age 1 HI 1/ day day 21 day 42 WV >35 years of age 2 day day 21 day 42 SU >35yr day day 21 day 42 day day 21 day 42
21 Effect of H2N2 exposure on H9N2 neutralizing antibody 2 15 MN titer Year of birth Stephenson Lancet 362:1959, 23
22 Critical issues [4] Dose-sparing role of adjuvants should be evaluated by direct comparison of adjuvanted and non-adjuvanted vaccine Do potential production advantages of WV vaccine warrant further evaluation? Impact of prior exposure to related HA should be considered Optimal testing strategy and results may differ between subtypes
23 Current H5 vaccine candidates Seed virus reverse genetically engineered A/Vietnam Manufactured by Sanofi Aventis and Chiron Subunit vaccine Represent new strain manufactured with licensed manufacturing
24 Development plan H5N1 Clinical evaluation Safety labs Vaccine Immunogenicity Screen 7.5 ug (n=25) 15 ug (n=25) 45 ug (n=25) 9 ug (n=25) P (n=13)
25 Development plan H5N1 Clinical evaluation Safety labs Vaccine Immunogenicity Screen 7.5 ug (n=25) 15 ug (n=25) 45 ug (n=25) 9 ug (n=25) P (n=13) DSMB
26 Development plan H5N1 Clinical evaluation Safety labs Vaccine Immunogenicity Screen 7.5 ug (n=25) 15 ug (n=25) 45 ug (n=25) 9 ug (n=25) P (n=13) DSMB
27 Development plan H5N1 Clinical evaluation Safety labs Vaccine Immunogenicity Screen 7.5 ug (n=25) 15 ug (n=25) 45 ug (n=25) 9 ug (n=25) P (n=13) DSMB Screen 7.5 ug (n=75) 15 ug (n=75) 45 ug (n=75) 9 ug (n=75) P (n-37)
28 Development plan H5N1 bs Vaccine Immunogenicity Assess results MB 7.5 ug (n=75) 15 ug (n=75) 45 ug (n=75) 9 ug (n=75) P (n-37)
29 Development plan H5N1 bs Vaccine Immunogenicity Elderly - lowest immunogenic dose - higher dose Assess results MB 7.5 ug (n=75) 15 ug (n=75) 45 ug (n=75) 9 ug (n=75) P (n-37)
30 Development plan H5N1 bs Vaccine Immunogenicity Elderly - lowest immunogenic dose - higher dose Assess results MB Children - lowest immunogenic dose - lower dose 7.5 ug (n=75) 15 ug (n=75) 45 ug (n=75) 9 ug (n=75) P (n-37)
31 Evaluation of inactivated vaccines: Objectives Determine the lowest dose resulting in a potentially protective immune response in the greatest proportion of people with an acceptable level of safety. Gain experience with the logistical issues involved in producing a pandemic vaccine
32 Find the lowest dose Whole virus vs. subunit Egg grown vs. cell culture or other substrates Adjuvants Alum and MF59 are currently licensed Schedule and route of administration Intradermal, transcutaneous, intranasal
33 Device for intradermal vaccination Removable clip for controlled deaeration Gaurd 27G needle
34 Intradermal vaccination: post vaccination GMT and response rate (%) 8 8 GMT post vaccination HI antibody IM ID H1 H3 B H1 H3 B 1 IM ID 18-6 yo > 6
35 Responses to 15 ug or 7.5 ug IM in adults 2 Half dose Full dose * GMT 12 8 * * GMT H1N1 H3N2 B H1N1 H3N2 B Subjects with history of vaccination in the last three years Subjects with no history of previous vaccination in the last three years
36 Determine the immune response Assays: HI assay insensitive for avian viruses Neutralization SRH Protective levels not defined Role of mechanisms other than serum antibody are unknown
37 Protect the greatest proportion of people Majority of studies will be done in healthy adults Safety and immunogenicity may be different in children Evaluation of priming strategies Need to evaluate pandemic vaccines in groups that respond poorly to conventional vaccine
38 Acceptable level of safety Defining acceptable safety parameters Considerations of sample size related to detection rates for rare events Safety considerations may favor conventional (licensed) approaches Tolerability may be different in different populations
39 Evaluation of live attenuated vaccines (CAIV) Highly immunogenic in susceptible populations Critical need to define correlates of immunity Potential use of low doses Studies should evaluate full range Induction of mucosal immunity might reduce transmission Development of challenge models
40 Evaluation of live attenuated vaccines (CAIV) Potential cross protection Evaluate responses to range of antigenic variants Not licensed in all populations Critical need to expand safety database Define correlates of immunity that could be extended to elderly Concerns regarding transmission and reassortment Clearly define conditions of deployment, expected shedding patterns, and biologic behavior of reassortants
41 Experimental Approaches Nasal inactivated vaccines Cross protective peptides/epitopes Virus-like particles Alternative live vaccines Vectored approaches DNA Vaccines
42 Considerations for alternate approaches Validation in clinical studies Extensive safety evaluation Specific markers of efficacy Individualized development strategy Need for early determination of potential advantages against conventional approaches
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