TABLE 5.2 Predictions Table—Secondary
|
Pathogen (Target Population) |
Type of Vaccine |
Clinical Trial Difficulty |
|
Dengue virus (Infants and children in endemic areas; travelers to endemic areas) |
Attenuated live vector virus containing gene for broadly cross-reacting protective antigen |
Phase I trials must be in adults, in nonendemic areas. Some apprehension over possible enhancement effects for dengue and with new approach |
|
Escherichia coli (enterotoxigenic) (Infants < 6 months) |
A combination of purified colonization factor antigens and possibly other antigens |
Moderate. High attack rate in children and travelers makes evaluation possible in relatively small population. But may need to evaluate protection against certain serotypes or CFA types |
|
Genetically engineered attenuated strains |
Needs careful monitoring for reversion to virulence |
|
|
Hemophilus influenzae type b (Infants) |
Conjugated polysaccharide |
Need to be carried out in very young children |
|
Hepatitis A virus (Susceptibles of all ages; routine for preschool children) |
Attenuated live virus |
Large number of subjects needed. Initial trials in adults may give false concepts of immunogenicity and reactogenicity for children |
|
Polypeptide recombinant vaccine produced in yeast |
Large number of subjects needed |
|
|
Hepatitis B virus (Areas with high perinatal infection: all infants at birth (if possible). Other areas: all infants, simultaneous with other vaccinations, at earliest possible age) |
Polypeptide produced by recombinant DNA technology |
Relatively simple |
|
Japanese encephalitis virus (Children in epidemic and endemic areas; foreign visitors to epidemic regions) |
Inactivated virus produced in cell culture |
Difficult. Low clinical attack rate requires very large number of subjects. |
|
Mycobacterium leprae (Immunoprophylactic: all children in endemic areas. Immuno therapeutic: all recently infected individuals) |
Armadillo-derived M. leprae |
Low incidence and long incubation period requires many subjects and long time for trials |
|
Neisseria meningitidis (Infants, 3 to 6 months) |
Conjugated capsular polysaccharides, Groups A,C,Y, and W135 |
Difficult because epidemic disease is unpredictable |
|
Parainfluenza viruses (Infants) |
Trivalent, subunit vaccine (which must contain fusion proteins) |
|
|
Plasmodium spp. (All infants at risk, military personnel, travelers) |
Plasmodium falciparum, synthetic or recombinant sporozoite antigen preparation |
Mosquito challenge to volunteers |
|
Multivalent synthetic or recombinant sporozoite antigen preparation (P. falciparum, P. vivax, P. ovale, P. malariae) |
Mosquito challenge to volunteers |