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Tabell vaksineforsøk med MenBvac (engelsk)

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Nedenfor finner du en oversikt over vaksineforsøk med MenBvac mot smittsom hjernehinnebetennelse (meningokokksykdom). Tabellene er på engelsk.


Phase I study

 

 

 

No. of Subjects

Study

Age Group

Objective

MenBvac/PC/PCA

Controls

I-1

Adult males (25-50 yrs)

Safety, one dose of  MenBvac (PA)*, PC*, or PCA*; dose ranging 14/25/50/75/100mg

18

0

*P: Outer Membrane vesicles from serogroup B meningococci (OMV), C: Polysaccharide from serogroup C meningococci (PS-C), and AAluminum hydroxide used as adjuvant [Al (OH)3]. MenBvac (PA) =P+A; PC=P+C; PCA=P+C+A.

Phase II studies including a 2nd dose (6 weeks interval) regime

Study

Age Group

Objective

MenBvac/PC/PCA

Controls

II-1, Stages 1-3

Adults

Immunogenicity and reactogenicity, comparing different formulations (MenBvac (PA)*, PC*, or PCA*) and doses (12.5/25/50/100mg)

223 MenBvac
39 PC
89 PCA

84

II-4A/B

Adults

Immunogenicity (A) and reactogenicity (B) of MenBvac (new lot)

4A:17
4B: 238

4A:0
4B:32

89-02

Adolescents
(13-14 yrs)

Immunogenicity and safety in the same population as in III-B,  MenBvac vs. placebo

585

295

90-01

Adults

Immunogenicity and safety in the same population as in III-A,  MenBvac vs. placebo

207

105

90-03

Adults

MenBvac, lot to lot consistency, 2 production lots

296

75

 *P: Outer Membrane vesicles from serogroup B meningococci (OMV), C: Polysaccharide from serogroup C meningococci (PS-C), and A: Aluminum hydroxide used as adjuvant [Al (OH)3].  MenBvac (PA) =P+A; PC=P+C; PCA=P+C+A. Placebo: Aluminum hydroxide in vaccine solvent

Phase III Studies

Study

Age Group

Objective

No. of Subjects

MenBvac

Controls

III-A

Adults

Efficacy after 1 dose in military recruits, MenBvac vs. placebo

27,400

27,200

III-B

Adolescents
(13-16 yrs)

Efficacy, MenBvac vs. placebo, 2 doses, 6 weeks interval

88,800

83,000

III-C

Adolescents(13-16 yrs)

Open follow-up of III-B, MenBvac, 2 doses

 

49,000
(+ 88,800  from III-B)

64,600

 

Phase II studies including a 3rd and 4th dose regime

 

 

 

No. of Subjects

Study

Age Group

Objective

MenBvac

Controls

91-01 +

 II-11

Adults

Effect of a booster dose, previous phase II trial participants given 3rd  vaccine dose 4 to 6 years later

37

0

92-02

Adolescents(13-14 yrs)

Effect of a booster dose after 10 months, MenBvac vs. control vaccine

311

 

62

 

II-12

Adults

Cellular immunity, MenBvac (0, 6 weeks, 10 months)

10

0

WHO initiated study

Young adults(15-20 yrs)

MenBvac vs. Cuban meningococcal B vaccine, 2 doses vs. 3 doses (0, 6 weeks,  10 months), Iceland

153

255

WHO initiated study

Infants, Toddlers and Adults

MenBvac vs. Cuban meningococcal B vaccine; 3 doses (0, 2 and 4 months), Chile

62 (at  2, 4 and 6 m)
61 (2-4 yrs)
57 (17-30 yrs)

125
122
116

6308

Adults

MenBvac, 3 doses at 8 weeks intervals, USA  

20

0

98-03

Adults

Immunogenicity and safety of a combination of MenBvac and Menjugate*

19 MenBvac
35 MenBvac+ Menjugate
19 Menjugate 

00-02

Adolescents(12-17 yrs)

Persisting immune responses indicating long-term protection after booster dose with meningococcal group B outer membrane vesicle vaccine

248 (at 0)
232 (at 6 w)
226 (at 12 w)
209 (at 12 m)

126
123
119
111 

01-01 (A)

Adults

Immunogenicity and safety of a combination of two serogroup B meningococcal outer membrane vesicle vaccines

30 MenBvac(0)
27 MenBvac (6w)
27 MenBvac (12w)

30 MeNZB
30 MeNZB
29 MeNZB

31 Combined
30 Combined
30 Combined

01-01 (B)

 

Same study and publication as above

  6 MenBvac (12m)
13 MeNZB    (12m)

5 MenBvac
9 MeNZB

19 Combined

 * Menjugate is a meningococcal serogroup C conjugate vaccine manufactured by Chiron S.p.A.

Phase II studies in New Zealand

 

 

 

No. of Subjects

Study

Age Group

Objective

MeNZB

Controls

 

Adults (18-50 yrs)

Safety and immunogenicity of New Zealand strain meningococcal serogroup B OMV vaccine in healthy adults: Beginning of epidemic control

NZ cand 25µg
25 (at 0)
24 (at 6w)
24 (at 12w)

NZ cand 50µg
24
23
23

MenBvac 25µg
26
26
26

 

Preteens (8-12 yrs)

Immunogenicity, reactogenicity and safety of a P1.7b.4 Strain-specific serogroup B meningococcal vaccine given to preteens

NIPH-MeNZB
237 (at 0)
231 (at 6w)
227 (at 12w

MenBvac
61
58
57

CV-MeNZB
248
243
240

NIPH-MeNZB
62
59
59

 

Children (16-24 mndr)

New Zealand epidemic strain meningococcal B outer membrane vesicle vaccine in children aged 16-24 months

261 (at 0)
256 (at 6w)
255 (at 12w)

64 MenBvac
62 MenBvac
61 MenBvac

 

Infants (6-8 mndr)

Phase II meningococcal B vesicle vaccine trial in New Zealand infants

235 (at 0)
233 (at 6w)
232 (at 12w)

59 MenC conjugate
59 MenC conjugate
59 MenC conjugate