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How Effective is Hib Vaccine?


How effective is Hib vaccine?

According to the CDC, 95 percent of infants vaccinated with two or three doses of Hib conjugate vaccines will develop antibodies thought to be indicative of protection against Haemophilus influenzae type b invasive disease, however, the duration of vaccine acquired immunity from Hib vaccines is unknown. 1

The immunogenicity of Hib vaccine varies with severity of immunocompromised and stage of infection in persons with HIV infection.  The CDC reports Hib vaccines to be effective in persons considered at higher risk for invasive disease, including persons with HIV infection, asplenia, leukemia, and sickle cell disease, however, no efficacy studies have ever been completed to determine the actual effectiveness of the use of Hib vaccines in these high risk populations.2

  • ActHIBAccording to the manufacturer’s product insert, ActHIB induces antibodies in 90 percent of infants after the primary series and 98 percent of infants after a booster dose. However, Native Americans, a population noted to be at greater risk of Hib invasive disease, have also been found to have a lower immune response to Hib conjugate vaccines. Sanofi Pasteur reports that following a full three doses of the vaccine administered between 6 weeks and 6 months of age, only 75 percent of Native American infants were found to have acceptable antibody levels. In children with sickle cell anemia, only 89 percent of children were found to have acceptable antibodies after two doses of ActHIB. If ActHIB is administered to immunosuppressed individuals, including those receiving immunosuppressive therapy, expected antibody responses may not be obtained. This population includes patients with asymptomatic or symptomatic HIV-infection, severe combined immunodeficiency, hypogammaglobulinemia or agammaglobulinemia; altered immune status due to diseases such as leukemia, lymphoma, or generalized malignancy, or an immune system compromised by treatment with corticosteroids, alkylating drugs, antimetabolites or radiation.3
  • HIBERIXBased on a clinical efficacy study with unconjugated Haemophilus b polysaccharide vaccine and data from passive antibody studies, an anti-PRP concentration of 0.15 mcg/mL is considered to be the minimal protective level against Hib invasive disease. Data collected from an efficacy study of unconjugated Haemophilus b polysaccharide vaccine indicates that an anti-PRP concentration of ≥1.0 mcg/mL is predictive of protection against invasive Hib disease through at least a one-year period. In vaccine efficacy studies, these two particular antibody levels have been used to evaluate the effectiveness of Haemophilus b conjugate vaccines, including HIBERIX. According to the HIBERIX product insert, one month following the completion of the three dose Hib primary vaccine series, 96.6 percent of infants were found to have passive antibodies equal to or greater than 0.15 mcg/mL while only 81.2 percent were found to have levels greater than or equal to 1.0 mcg/mL. One month following a booster dose of HIBERIX administered between 15 and 18 months of age, 100 percent of children were found to have passive antibodies equal to or greater than 0.15mcg/mL and 99.1 percent were found to have levels greater than or equal to 1.0 mcg/mL. The safety and effectiveness of HIBERIX in immunosuppressed children, including children receiving immunosuppressive therapy, has not been evaluated and if administered to this population, the expected immune response may not be obtained. Immunosuppressive therapies that may reduce immune response to HIBERIX include irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids used in greater than physiologic doses.4
  • PedvaxHIB — According to the manufacturer’s product insert, the protective efficacy of PedvaxHIB measured during clinical trials of high-risk populations was estimated to be 93 to 100 percent, depending on the age of the child. For the maintenance of vaccine induced antibody levels, a booster dose of PedvaxHIB is required in infants who complete the primary two-dose regimen prior to 12 months of age.5
  • Pentacel — According to the manufacturer’s product insert, the protective efficacy of the pentavalent vaccine Pentacel may not extend to all individuals. If Pentacel is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. Immunosuppressive therapies, including irradiation, antimetabolities, alkylating agents, cytotoxic drugs and corticosteroids used in greater than physiologic doses may also reduce the immune response to Pentacel. Neither the safety nor the effectiveness of Pentacel in infants less than 6 weeks old or in children ages 5 to 16 years old have been established.

    In clinical studies with Pentacel, efficacy was measured by antibody responses to the individual five disease components contained in the vaccine. The efficacy against pertussis, which has no well-established serological correlate of protection, is based in part on a comparison of pertussis immune responses following Pentacel vaccine in U.S. children to responses following Daptacel vaccine (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed―DTAP). Immune responses to Pentacel were evaluated in four U.S. studies.

    The efficacy for diphtheria one month following three and four doses of Pentacel was determined to be between 98 and 100 percent. Tetanus antibodies were reported at 99.7 to 100 percent. Pertussis efficacy was reported at 68.8 to 95.8 percent, depending on the study. Protective antibodies against poliomyelitis with Pentacel in clinical trials were reported at 99.4 percent. Hib antibodies were found to be 90 to 98.2 percent, depending on the study.6
  • VAXELIS – In VAXELIS pre-licensing clinical trials, efficacy was measured by examining antibody responses to the individual six disease components found in the vaccine. Immune responses were evaluated by the manufacturers one month following completion of the three dose VAXELIS vaccine series. The efficacy for diphtheria following three doses of VAXELIS was found to be 82.4 percent. Tetanus antibodies were reported to be at 99.9 percent. Testing on the pertussis antibody efficacy examined the 4 components of pertussis. The anti-PT response was found to be at 98.1 percent, the anti-FHA response was 87.3 percent, the anti-PRN response was 79.3 percent and the anti-FIM response was found to be at 90.2 percent. Protective antibodies to all three types of poliomyelis in VAXELIS clinical trials were reported to be at 100 percent. 97.3 percent of clinical trial participants were found to have anti-PRP levels greater than or equal to 0.15 ug/mL while 85 percent were noted to have anti-PRP levels greater than or equal to 1.0 ug/mL. Anti-PRP levels greater than or equal to 1.0 ug/mL measured three weeks following Hib vaccination are considered to be predictive of protection for one year. Hepatitis B antibodies following the administration of three doses of VAXELIS were reported to be at 99.4 percent.

Data on the safety and effectiveness of using VAXELIS following the use of one or two doses of DTaP, IPV, HIB, or hepatitis B vaccine manufactured by another vaccine maker is not available. The protective efficacy of the hexavalent vaccine VAXELIS may not extend to all individuals. If VAXELIS is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

While Hib vaccines have been reported to be highly effective by vaccine manufacturers, independent studies have noted that vaccine failure can occur, resulting in invasive Hib disease.7 8 Additionally, several studies have found an increase in non-b type invasive H. influenzae infections since Hib vaccines were first introduced.9 H. influenzae type e10 and type f11 have increased in the United States while Northern Canada and Alaska have noted a significant increase in H. influenzae type a invasive disease.12 13 14 15 An increase in H. influenzae type a was also noted among children in Utah.16 Brazil experienced a substantial increase in H. influenzae type a meningitis following the introduction of vaccines targeting H. influenzae type b.17 In Ontario Canada, following the introduction of Hib vaccines, nontypeable and type f H. influenzae invasive disease have reportedly replaced H. influenzae type b in children under the age of five.18  Further, since the introduction of both Hib conjugate vaccines and pneumococcal conjugate vaccines, nontypeable H. influenzae has emerged as a serious health threat.19 While nontypeable H. influenzae is most noted to be associated with otitis media and sinusitis in children as well as acute exacerbation of chronic obstructive pulmonary disease (COPD) in adults, it can also result in invasive disease.20

Hib vaccines can offer protection from invasive H. influenzae type b infections, however, they are not protective against invasive disease caused by non-b type or nontypeable H. influenzae.21 Moreover, the long-term effectiveness of Hib vaccines is not known at this time.22

IMPORTANT NOTE: NVIC encourages you to become fully informed about Haemophilus Influenzae Type B (Hib) and the Hib vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

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References

1 CDC Vaccines and Preventable Diseases – About Hib Vaccines Feb 13, 2018

2 Ibid

3 FDA ActHIB Product Insert Dec. 20, 2018

4 FDA Hiberix Product Insert Apr. 30, 2018

5 FDA Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate) Apr. 27, 2011

6 FDA Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Mar. 16, 2017

7 Lee YC, Kelly DF, Yu LM et al. Haemophilus influenzae type b vaccine failure in children is associated with inadequate production of high-quality antibody. Clin Infect Dis. 2008 Jan 15;46(2):186-92

8 J McVernon, P Johnson, A Pollard, et al. Immunologic memory in Haemophilus influenzae type b conjugate vaccine failure Arch Dis Child. 2003 May; 88(5): 379–383.

9 Campos J, Hernando M, Román F et al. Analysis of invasive Haemophilus influenzae infections after extensive vaccination against H. influenzae type b. J Clin Microbiol. 2004 Feb;42(2):524-9.

10 Waggoner-Fountain LA, Hendley JO, Cody EJ et al. The emergence of Haemophilus influenzae types e and f as significant pathogens. Clin Infect Dis. 1995 Nov;21(5):1322-4.

11 Urwin G, Krohn JA, Deaver-Robinson K et al. Invasive disease due to Haemophilus influenzae serotype f: clinical and epidemiologic characteristics in the H. influenzae serotype b vaccine era. The Haemophilus influenzae Study Group. Clin Infect Dis. 1996 Jun;22(6):1069-76.

12 Boisvert A-A, Moore D Invasive disease due to Haemophilus influenzae type A in children in Canada’s north: A priority for prevention Can J Infect Dis Med Microbiol. 2015 Nov-Dec; 26(6): 291–292.

13 Bruce MG, Deeks SL, Zulz T et al. Epidemiology of Haemophilus influenzae serotype a, North American Arctic, 2000-2005. Emerg Infect Dis. 2008 Jan;14(1):48-55.

14 Rotondo JL, Sherrard L, Helferty M et al. The epidemiology of invasive disease due to Haemophilus influenzae serotype a in the Canadian North from 2000 to 2010. Int J Circumpolar Health. 2013 Aug 5;72

15 Ulanova M, Tsang RSW Haemophilus influenzae serotype a as a cause of serious invasive infections. Lancet Infect Dis. 2014 Jan;14(1):70-82

16 Bender JM, Cox CM, Mottice S et al. Invasive Haemophilus influenzae disease in Utah children: an 11-year population-based study in the era of conjugate vaccine. Clin Infect Dis. 2010 Apr 1;50(7):e41-6

17 Ribeiro GS, Reis JN, Cordeiro SM et al Prevention of Haemophilus influenzae type b (Hib) meningitis and emergence of serotype replacement with type a strains after introduction of Hib immunization in Brazil. J Infect Dis. 2003 Jan 1;187(1):109-16.

18 Adam HJ, Richardson SE, Jamieson FB et al. Changing epidemiology of invasive Haemophilus influenzae in Ontario, Canada: evidence for herd effects and strain replacement due to Hib vaccination. Vaccine. 2010 May 28;28(24):4073-8

19 Cerquetti M, Giufrè M Why we need a vaccine for non-typeable Haemophilus influenzae. Hum Vaccin Immunother. 2016 Sep; 12(9): 2357–2361.

20 Langere JD, de Jonge MI Invasive Disease Caused by Nontypeable Haemophilus influenzae Emerg Infect Dis. 2015 Oct; 21(10): 1711–1718.

21 CDC Haemophilus influenzae Disease (Including Hib) For Clinicians – Immunization Feb. 13, 2018

22 CDC About Hib Vaccines - Immunogenicity and Vaccine Efficacy Feb 13, 2018


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